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FDA 510(k)

FLOWCLAMP CAT.#1011 & 1012

K-Number: K802009 · 1980-10-31

ApplicantPollak (Intl.), Ltd.
Decision Date1980-10-31
Product CodeFKK
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

FLOWCLAMP CAT.#1011 & 1012 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 1980-10-31 under 510(k) number K802009. The device is classified under product code FKK. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FLOWCLAMP CAT.#1011 & 1012?

FLOWCLAMP CAT.#1011 & 1012 is a medical device that received FDA 510(k) clearance on 1980-10-31. The listed applicant is Pollak (Intl.), Ltd.. The 510(k) number is K802009.

When did FLOWCLAMP CAT.#1011 & 1012 receive FDA 510(k) clearance?

FLOWCLAMP CAT.#1011 & 1012 received FDA 510(k) clearance on 1980-10-31, under 510(k) number K802009.

Who is the listed applicant for FLOWCLAMP CAT.#1011 & 1012?

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 FLOWCLAMP CAT.#1011 & 1012?

The FDA product code for FLOWCLAMP CAT.#1011 & 1012 is FKK.

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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.#1118K802017DRESSING CHANGE SET CAT.#910-930K802007PEDIWET=GUAZE IMPREGNATED WITH PETROL

View all 31 devices →

Related Devices (Code: FKK)

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.

K854512TUBING CLAMP CAT#1000-ARao Medical Devices, Inc.K854517NEW TRAVENOL ROLLER CLAMP-SOLUTION ADMIN. SETTravenol Laboratories, S.A.K844121CLAMP, TUBING, LINEDyn-A-Med ProductsK831689EMPTY DIALYSATE CONTAINERDelmed, Inc.K822551AMP CAPD UNISPIKE AMINISTRATION SETAmerican Medical Products, 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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