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FDA 510(k)

TRIBAG, URINE BAG SYSTEM #1109,& 1301-12

K-Number: K802012 · 1980-09-09

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

Device Summary

TRIBAG, URINE BAG SYSTEM #1109,& 1301-12 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 K802012. The device is classified under product code KNX. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TRIBAG, URINE BAG SYSTEM #1109,& 1301-12?

TRIBAG, URINE BAG SYSTEM #1109,& 1301-12 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 K802012.

When did TRIBAG, URINE BAG SYSTEM #1109,& 1301-12 receive FDA 510(k) clearance?

TRIBAG, URINE BAG SYSTEM #1109,& 1301-12 received FDA 510(k) clearance on 1980-09-09, under 510(k) number K802012.

Who is the listed applicant for TRIBAG, URINE BAG SYSTEM #1109,& 1301-12?

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 TRIBAG, URINE BAG SYSTEM #1109,& 1301-12?

The FDA product code for TRIBAG, URINE BAG SYSTEM #1109,& 1301-12 is KNX.

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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: KNX)

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.

K110518IBAGFuture Path Medical, LLCK9733644L DRAINAGE BAG, 4L BAG FOR PERITONEAL DIALYSIS, 4L URINARY DRAINAGE BAGMaersk Medical A/SK972887MEDLINE PREMIUM LEG BAG, MEDLINE FABRIC BAC LEG BAG, MEDLINE URINARY LEG BAGMedline Industries, Inc.K971271BESECURE EXTERNAL URINARY COLLECTION SYSTEMUrology Research Intl., Inc.K971929AMSINO URINARY LEG BAGAmsino Intl., Inc.K971764WELCON HUE-VU URINARY DRAINAGE BAGWelcon, 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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