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FDA 510(k)

EXPANDACELL INJECTO-PAK NASAL PACK

K-Number: K954845 · 1995-11-27

ApplicantShippert Medical Technologies Corp.
Decision Date1995-11-27
Product CodeEMX
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

EXPANDACELL INJECTO-PAK NASAL PACK is the device name listed in this FDA 510(k) record. The listed applicant is Shippert Medical Technologies Corp.. It received FDA 510(k) clearance on 1995-11-27 under 510(k) number K954845. 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 EXPANDACELL INJECTO-PAK NASAL PACK?

EXPANDACELL INJECTO-PAK NASAL PACK is a medical device that received FDA 510(k) clearance on 1995-11-27. The listed applicant is Shippert Medical Technologies Corp.. The 510(k) number is K954845.

When did EXPANDACELL INJECTO-PAK NASAL PACK receive FDA 510(k) clearance?

EXPANDACELL INJECTO-PAK NASAL PACK received FDA 510(k) clearance on 1995-11-27, under 510(k) number K954845.

Who is the listed applicant for EXPANDACELL INJECTO-PAK NASAL PACK?

The FDA 510(k) record lists Shippert Medical Technologies Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EXPANDACELL INJECTO-PAK NASAL PACK?

The FDA product code for EXPANDACELL INJECTO-PAK NASAL PACK is EMX.

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Other records listing Shippert Medical Technologies 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.

K102117TISSU TRANS FILTRON SYRINGE FILLK092482TISSU TRANS FILTRON, MODELS 3-TT-FILTRON 2000-500K092022TISSU TRANS HARVEST TUBINGK050797TISSU-TRANSK964855EXPANDACELL EYE SPEAR, EYE WICK, WICK DRAIN AND CORNEAL SHIELDK964334EXPANDACELL ANTI-FOG INSTRUMENT WIPE (WITH ALCOHOL)/(WITHOUT)

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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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