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FDA 510(k)

URINE SPECIMEN CONTAINER #'S 1013-1016

K-Number: K802002 · 1980-09-09

ApplicantPollak (Intl.), Ltd.
Decision Date1980-09-09
Product CodeFMH
Advisory CommitteePA
DecisionSubstantially Equivalent

Device Summary

URINE SPECIMEN CONTAINER #'S 1013-1016 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 1980-09-09 under 510(k) number K802002. The device is classified under product code FMH. It was reviewed by the PA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the URINE SPECIMEN CONTAINER #'S 1013-1016?

URINE SPECIMEN CONTAINER #'S 1013-1016 is a medical device that received FDA 510(k) clearance on 1980-09-09. The listed applicant is Pollak (Intl.), Ltd.. The 510(k) number is K802002.

When did URINE SPECIMEN CONTAINER #'S 1013-1016 receive FDA 510(k) clearance?

URINE SPECIMEN CONTAINER #'S 1013-1016 received FDA 510(k) clearance on 1980-09-09, under 510(k) number K802002.

Who is the listed applicant for URINE SPECIMEN CONTAINER #'S 1013-1016?

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 URINE SPECIMEN CONTAINER #'S 1013-1016?

The FDA product code for URINE SPECIMEN CONTAINER #'S 1013-1016 is FMH.

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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: FMH)

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.

K900983TRI-TECH URINE SPECIMEN KITTri-Tech, Inc.K823763VARIOUS-SPECIMEN COLLECTORSCordis Corp.K820180CALCULI FILTER CUPOmnimedicalK812933LANCER SPECIMEN CONTAINERSherwood Medical Co.K802340SPECIMEN SETAmerican Pharmaseal Div. AhscK800947MIDSTREAM COLLECTION KITSage 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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