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FDA 510(k)

SPONGE, SURGICAL, GAUZE, COMPRESSED 2 BY 2 INCHES

K-Number: K864175 · 1986-11-05

ApplicantFraass Survival Systems, Inc.
Decision Date1986-11-05
Product CodeEFQ
DecisionSubstantially Equivalent

Device Summary

SPONGE, SURGICAL, GAUZE, COMPRESSED 2 BY 2 INCHES is the device name listed in this FDA 510(k) record. The listed applicant is Fraass Survival Systems, Inc.. It received FDA 510(k) clearance on 1986-11-05 under 510(k) number K864175. The device is classified under product code EFQ. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPONGE, SURGICAL, GAUZE, COMPRESSED 2 BY 2 INCHES?

SPONGE, SURGICAL, GAUZE, COMPRESSED 2 BY 2 INCHES is a medical device that received FDA 510(k) clearance on 1986-11-05. The listed applicant is Fraass Survival Systems, Inc.. The 510(k) number is K864175.

When did SPONGE, SURGICAL, GAUZE, COMPRESSED 2 BY 2 INCHES receive FDA 510(k) clearance?

SPONGE, SURGICAL, GAUZE, COMPRESSED 2 BY 2 INCHES received FDA 510(k) clearance on 1986-11-05, under 510(k) number K864175.

Who is the listed applicant for SPONGE, SURGICAL, GAUZE, COMPRESSED 2 BY 2 INCHES?

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

What is the FDA product code for SPONGE, SURGICAL, GAUZE, COMPRESSED 2 BY 2 INCHES?

The FDA product code for SPONGE, SURGICAL, GAUZE, COMPRESSED 2 BY 2 INCHES is EFQ.

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Other records listing Fraass Survival Systems, 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.

K912022FRASTEC DRYNET, BRIDAL VEIL, VARIOUS SIZESK871437SURVIVAL KIT, INDIVIDUALK871434MEDICAL PACKET, INDIVIDUAL SURVIVAL KIT, AIRMAN'SK871458SURVIVAL KIT, INDIVIDUAL, TROP, TACTICAL AIR CREWK871916FRASTEC DRY BURN DRESSINGK871917FRASTEC DRY GAUZE 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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