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FDA 510(k)

PEDIWET=GUAZE IMPREGNATED WITH PETROL

K-Number: K802007 · 1980-09-26

ApplicantPollak (Intl.), Ltd.
Decision Date1980-09-26
Product CodeFRQ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

PEDIWET=GUAZE IMPREGNATED WITH PETROL 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 1980-09-26 under 510(k) number K802007. The device is classified under product code FRQ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PEDIWET=GUAZE IMPREGNATED WITH PETROL?

PEDIWET=GUAZE IMPREGNATED WITH PETROL is a medical device that received FDA 510(k) clearance on 1980-09-26. The listed applicant is Pollak (Intl.), Ltd.. The 510(k) number is K802007.

When did PEDIWET=GUAZE IMPREGNATED WITH PETROL receive FDA 510(k) clearance?

PEDIWET=GUAZE IMPREGNATED WITH PETROL received FDA 510(k) clearance on 1980-09-26, under 510(k) number K802007.

Who is the listed applicant for PEDIWET=GUAZE IMPREGNATED WITH PETROL?

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 PEDIWET=GUAZE IMPREGNATED WITH PETROL?

The FDA product code for PEDIWET=GUAZE IMPREGNATED WITH PETROL is FRQ.

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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: FRQ)

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.

K914887ESOPHAGEAL STETHOSCOPE W/TEMP SENSOR/GASTRIC SUCTMallinckrodt MedicalK914530ICAN GT DRAINAGE BAGIcn Pharmaceuticals, 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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