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FDA 510(k)

IVALON NASAL PACKING W/DRAWSTRING (8.0CM & 4.5CM), IVALON NASAL PACKING W/AIRWAY TUBE & DRAWSTRING, IVALON CONTOUR NASAL

K-Number: K964113 · 1996-11-07

ApplicantM-Pact Worldwide Management Corp.
Decision Date1996-11-07
Product CodeEMX
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

IVALON NASAL PACKING W/DRAWSTRING (8.0CM & 4.5CM), IVALON NASAL PACKING W/AIRWAY TUBE & DRAWSTRING, IVALON CONTOUR NASAL is the device name listed in this FDA 510(k) record. The listed applicant is M-Pact Worldwide Management Corp.. It received FDA 510(k) clearance on 1996-11-07 under 510(k) number K964113. The device is classified under product code EMX. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IVALON NASAL PACKING W/DRAWSTRING (8.0CM & 4.5CM), IVALON NASAL PACKING W/AIRWAY TUBE & DRAWSTRING, IVALON CONTOUR NASAL?

IVALON NASAL PACKING W/DRAWSTRING (8.0CM & 4.5CM), IVALON NASAL PACKING W/AIRWAY TUBE & DRAWSTRING, IVALON CONTOUR NASAL is a medical device that received FDA 510(k) clearance on 1996-11-07. The listed applicant is M-Pact Worldwide Management Corp.. The 510(k) number is K964113.

When did IVALON NASAL PACKING W/DRAWSTRING (8.0CM & 4.5CM), IVALON NASAL PACKING W/AIRWAY TUBE & DRAWSTRING, IVALON CONTOUR NASAL receive FDA 510(k) clearance?

IVALON NASAL PACKING W/DRAWSTRING (8.0CM & 4.5CM), IVALON NASAL PACKING W/AIRWAY TUBE & DRAWSTRING, IVALON CONTOUR NASAL received FDA 510(k) clearance on 1996-11-07, under 510(k) number K964113.

Who is the listed applicant for IVALON NASAL PACKING W/DRAWSTRING (8.0CM & 4.5CM), IVALON NASAL PACKING W/AIRWAY TUBE & DRAWSTRING, IVALON CONTOUR NASAL?

The FDA 510(k) record lists M-Pact Worldwide Management Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IVALON NASAL PACKING W/DRAWSTRING (8.0CM & 4.5CM), IVALON NASAL PACKING W/AIRWAY TUBE & DRAWSTRING, IVALON CONTOUR NASAL?

The FDA product code for IVALON NASAL PACKING W/DRAWSTRING (8.0CM & 4.5CM), IVALON NASAL PACKING W/AIRWAY TUBE & DRAWSTRING, IVALON CONTOUR NASAL is EMX.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing M-Pact Worldwide Management Corp. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K971832IVALON PVA SURGICAL SPEAR, IVALON EYE DRAIN, 80CC, IVALON EYE DRAIN, 400CC, IVALON EYE WICKK971473IVALON INSTRUMENT WIPE, IVALON KNIFE CLEANING BLOCK

Related Devices (Code: EMX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K220326PosiSep X BAM Hemostat Dressing/Intranasal SplintHemostasis, LLCK041446NASALCEASELes Laboratorires Brothier, S.A.K000108RAPID RHINO-ANTERIOR 90MM, MODEL RR-A 90, RAPID RHINO-POSTERIOR 100MM, MODEL RR-P 100Bhk HoldingK993362HYLASINEBiomatrix, Inc.K983276HYDROFERA BACTERISTATIC NASAL DRESSINGHydrofera, LLCK982731MEROGEL NASAL DRESSING AND SINUS STENTXomed, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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