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FDA 510(k)

TRACHEOTOMY SPONGE, NON-WOVEN DELNET

K-Number: K792618 · 1980-01-09

ApplicantAmerican Medical Disposable, Inc.
Decision Date1980-01-09
Product CodeEFQ
DecisionSubstantially Equivalent

Device Summary

TRACHEOTOMY SPONGE, NON-WOVEN DELNET 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 K792618. The device is classified under product code EFQ. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TRACHEOTOMY SPONGE, NON-WOVEN DELNET?

TRACHEOTOMY SPONGE, NON-WOVEN DELNET 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 K792618.

When did TRACHEOTOMY SPONGE, NON-WOVEN DELNET receive FDA 510(k) clearance?

TRACHEOTOMY SPONGE, NON-WOVEN DELNET received FDA 510(k) clearance on 1980-01-09, under 510(k) number K792618.

Who is the listed applicant for TRACHEOTOMY SPONGE, NON-WOVEN DELNET?

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-WOVEN DELNET?

The FDA product code for TRACHEOTOMY SPONGE, NON-WOVEN DELNET is EFQ.

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Other records listing American Medical Disposable, 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.

K833734NEUROLOGICAL SPONGE ON PLASTIC STICKK833735AN ODOR ABSORBENT BANDAGEK833730NON ADHERENT BANDAGE/SHEETK833731BREATHABLE OVERWRAY BANDAGE NON-ELASK833729ELASTIC BREATHABLE OVER-WRAP BANDAGEK833733NON - ADHERENT BANDAGE

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Related Devices (Code: EFQ)

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.

K991757NON-ABSORBABLE GAUZE FOR EXTERNAL USE, STERILE AND NON STERILEFurlong IndustriesK991215SYMTEX 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 IndustriesK984187CROSSTEX 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.

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