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FDA 510(k)

GUAZE BANDAGES CAT.#101-169

K-Number: K801996 · 1980-09-16

ApplicantPollak (Intl.), Ltd.
Decision Date1980-09-16
Product CodeNAB
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

GUAZE BANDAGES CAT.#101-169 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 K801996. The device is classified under product code NAB. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GUAZE BANDAGES CAT.#101-169?

GUAZE BANDAGES CAT.#101-169 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 K801996.

When did GUAZE BANDAGES CAT.#101-169 receive FDA 510(k) clearance?

GUAZE BANDAGES CAT.#101-169 received FDA 510(k) clearance on 1980-09-16, under 510(k) number K801996.

Who is the listed applicant for GUAZE BANDAGES CAT.#101-169?

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 BANDAGES CAT.#101-169?

The FDA product code for GUAZE BANDAGES CAT.#101-169 is NAB.

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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: NAB)

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.

K946015IVALON EXTERNAL SPONGEIvalonK940755ISOLYER (4X4, 8PLY)Isolyer Co.K931610OMNISORB II, NONWOVEN SPONGE, STERILE AND NONOmni Mfg., Inc.K925590MULTI-TRAUMA DRESSINGGam Industries, Inc.K926072K-BAND AND K-CREPEParema , Ltd.K915591STERILE GAUZE PADSEagle Medical, 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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