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FDA 510(k)

GAUZE SPONGES, INTERNAL AND EXTERNAL

K-Number: K905136 · 1991-03-06

ApplicantAmerican Healthcare Corp.
Decision Date1991-03-06
Product CodeEFQ
DecisionSubstantially Equivalent

Device Summary

GAUZE SPONGES, INTERNAL AND EXTERNAL is the device name listed in this FDA 510(k) record. The listed applicant is American Healthcare Corp.. It received FDA 510(k) clearance on 1991-03-06 under 510(k) number K905136. The device is classified under product code EFQ. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GAUZE SPONGES, INTERNAL AND EXTERNAL?

GAUZE SPONGES, INTERNAL AND EXTERNAL is a medical device that received FDA 510(k) clearance on 1991-03-06. The listed applicant is American Healthcare Corp.. The 510(k) number is K905136.

When did GAUZE SPONGES, INTERNAL AND EXTERNAL receive FDA 510(k) clearance?

GAUZE SPONGES, INTERNAL AND EXTERNAL received FDA 510(k) clearance on 1991-03-06, under 510(k) number K905136.

Who is the listed applicant for GAUZE SPONGES, INTERNAL AND EXTERNAL?

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

What is the FDA product code for GAUZE SPONGES, INTERNAL AND EXTERNAL?

The FDA product code for GAUZE SPONGES, INTERNAL AND EXTERNAL is EFQ.

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Other records listing American Healthcare 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.

K924192I.V. START KIT (AHC-50-54954K923941IRRIGATION TRAY W/ BULB SYRINGE & STERILE SALINEK923940IRRIGATION TRAY W/ PISTON SYRINGE & STERILE SALINEK923938IRRIGATION TRAY W/ PISTON SYRINGE & STERILE WATERK923939IRRIGATION TRAY W/ BULB SYRINGE & STERILE WATERK924193TRACHEOSTOMY CARE SET W/ HYDRO PEROX(AHC-20-54685)

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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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