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FDA 510(k)

STERILE GUAZE SWABS CAT.#301-420

K-Number: K802022 · 1980-09-16

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

Device Summary

STERILE GUAZE SWABS CAT.#301-420 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 K802022. The device is classified under product code EFQ. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STERILE GUAZE SWABS CAT.#301-420?

STERILE GUAZE SWABS CAT.#301-420 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 K802022.

When did STERILE GUAZE SWABS CAT.#301-420 receive FDA 510(k) clearance?

STERILE GUAZE SWABS CAT.#301-420 received FDA 510(k) clearance on 1980-09-16, under 510(k) number K802022.

Who is the listed applicant for STERILE GUAZE SWABS CAT.#301-420?

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 STERILE GUAZE SWABS CAT.#301-420?

The FDA product code for STERILE GUAZE SWABS CAT.#301-420 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

View all 31 devices →

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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