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FDA 510(k)

GUAZE BALLS CAT.#601-720

K-Number: K801999 · 1980-09-16

ApplicantPollak (Intl.), Ltd.
Decision Date1980-09-16
Product CodeEFQ
DecisionSubstantially Equivalent

Device Summary

GUAZE BALLS CAT.#601-720 is the device name listed in this FDA 510(k) record. The listed applicant is Pollak (Intl.), Ltd.. It received FDA 510(k) clearance on 1980-09-16 under 510(k) number K801999. The device is classified under product code EFQ. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GUAZE BALLS CAT.#601-720?

GUAZE BALLS CAT.#601-720 is a medical device that received FDA 510(k) clearance on 1980-09-16. The listed applicant is Pollak (Intl.), Ltd.. The 510(k) number is K801999.

When did GUAZE BALLS CAT.#601-720 receive FDA 510(k) clearance?

GUAZE BALLS CAT.#601-720 received FDA 510(k) clearance on 1980-09-16, under 510(k) number K801999.

Who is the listed applicant for GUAZE BALLS CAT.#601-720?

The FDA 510(k) record lists Pollak (Intl.), Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GUAZE BALLS CAT.#601-720?

The FDA product code for GUAZE BALLS CAT.#601-720 is EFQ.

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Other records listing Pollak (Intl.), Ltd. 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.

K000227UMBICUTK810049PEDICAT*K810050VECAFIX*K802011INFUSSION ALARM SYSTEM I.A.S. CAT.#1118K802009FLOWCLAMP CAT.#1011 & 1012K802017DRESSING CHANGE SET CAT.#910-930

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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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