FDA 510(k)

TRACHEOTOMY SPONGE, NON-ADHERENT BARRIER

K-Number: K792617 · 1980-01-09

ApplicantAmerican Medical Disposable, Inc.

Decision Date1980-01-09

Product CodeEFQ

DecisionSubstantially Equivalent

Device Summary

TRACHEOTOMY SPONGE, NON-ADHERENT BARRIER is the device name listed in this FDA 510(k) record. The listed applicant is American Medical Disposable, Inc.. It received FDA 510(k) clearance on 1980-01-09 under 510(k) number K792617. The device is classified under product code EFQ. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TRACHEOTOMY SPONGE, NON-ADHERENT BARRIER?

TRACHEOTOMY SPONGE, NON-ADHERENT BARRIER is a medical device that received FDA 510(k) clearance on 1980-01-09. The listed applicant is American Medical Disposable, Inc.. The 510(k) number is K792617.

When did TRACHEOTOMY SPONGE, NON-ADHERENT BARRIER receive FDA 510(k) clearance?

TRACHEOTOMY SPONGE, NON-ADHERENT BARRIER received FDA 510(k) clearance on 1980-01-09, under 510(k) number K792617.

Who is the listed applicant for TRACHEOTOMY SPONGE, NON-ADHERENT BARRIER?

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

What is the FDA product code for TRACHEOTOMY SPONGE, NON-ADHERENT BARRIER?

The FDA product code for TRACHEOTOMY SPONGE, NON-ADHERENT BARRIER is EFQ.

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Other records listing American Medical Disposable, Inc. as applicant

K833734NEUROLOGICAL SPONGE ON PLASTIC STICK K833735AN ODOR ABSORBENT BANDAGE K833730NON ADHERENT BANDAGE/SHEET K833731BREATHABLE OVERWRAY BANDAGE NON-ELAS K833729ELASTIC BREATHABLE OVER-WRAP BANDAGE K833733NON - ADHERENT BANDAGE

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Related Devices (Code: EFQ)

K991757NON-ABSORBABLE GAUZE FOR EXTERNAL USE, STERILE AND NON STERILEFurlong Industries K991215SYMTEX GAUZE PADS (1'S) AND SYMTEX GAUZE SPONGES STERILE 2'S AND STERILE 10'SSymtex Healthcare Corp.K990974VITOP DRESSINGWonder & Bioenergy Hi-Tech America, Inc.K990584GAUZE SPONGES: LAPAROTOMY SPONGE, X-RAY DETECTABLEBroadline Medical Industries K984187CROSSTEX NON-WOVEN SPONGESCrosstex Intl.K983016GAUZE, SPONGES, CAT # 11-003Vitalcare Group, 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.