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FDA 510(k)

CLOSED URINARY DRAINAGE BAG W/ANTI-REFLUX & PORT

K-Number: K880034 · 1988-03-02

ApplicantLin-Mark, Inc.
Decision Date1988-03-02
Product CodeKNX
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

CLOSED URINARY DRAINAGE BAG W/ANTI-REFLUX & PORT is the device name listed in this FDA 510(k) record. The listed applicant is Lin-Mark, Inc.. It received FDA 510(k) clearance on 1988-03-02 under 510(k) number K880034. 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 CLOSED URINARY DRAINAGE BAG W/ANTI-REFLUX & PORT?

CLOSED URINARY DRAINAGE BAG W/ANTI-REFLUX & PORT is a medical device that received FDA 510(k) clearance on 1988-03-02. The listed applicant is Lin-Mark, Inc.. The 510(k) number is K880034.

When did CLOSED URINARY DRAINAGE BAG W/ANTI-REFLUX & PORT receive FDA 510(k) clearance?

CLOSED URINARY DRAINAGE BAG W/ANTI-REFLUX & PORT received FDA 510(k) clearance on 1988-03-02, under 510(k) number K880034.

Who is the listed applicant for CLOSED URINARY DRAINAGE BAG W/ANTI-REFLUX & PORT?

The FDA 510(k) record lists Lin-Mark, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CLOSED URINARY DRAINAGE BAG W/ANTI-REFLUX & PORT?

The FDA product code for CLOSED URINARY DRAINAGE BAG W/ANTI-REFLUX & PORT is KNX.

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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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