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FDA 510(k)

ULTRASTAT NASAL CATHETER

K-Number: K901310 · 1990-06-14

ApplicantInvotec International, Inc.
Decision Date1990-06-14
Product CodeEMX
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

ULTRASTAT NASAL CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Invotec International, Inc.. It received FDA 510(k) clearance on 1990-06-14 under 510(k) number K901310. 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 ULTRASTAT NASAL CATHETER?

ULTRASTAT NASAL CATHETER is a medical device that received FDA 510(k) clearance on 1990-06-14. The listed applicant is Invotec International, Inc.. The 510(k) number is K901310.

When did ULTRASTAT NASAL CATHETER receive FDA 510(k) clearance?

ULTRASTAT NASAL CATHETER received FDA 510(k) clearance on 1990-06-14, under 510(k) number K901310.

Who is the listed applicant for ULTRASTAT NASAL CATHETER?

The FDA 510(k) record lists Invotec International, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ULTRASTAT NASAL CATHETER?

The FDA product code for ULTRASTAT NASAL CATHETER is EMX.

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Other records listing Invotec International, Inc. 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.

K122040INVOTEC LARYNGEAL ELECTRODEK080740CLEARVIEW ENDOSCOPE COVERK030492TITANIUM OSSICULAR REPLACMENT SYSTEMK973580INVOTEC CLEAN PADK973578INVOTEC EAR TAMPON (WICK) W/STRINGK971000EPISTAXIS NASAL PACK

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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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