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FDA 510(k)

URINARY DRAINAGE BAG

K-Number: K781987 · 1978-12-04

ApplicantKelsar Corp.
Decision Date1978-12-04
Product CodeKNY
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

URINARY DRAINAGE BAG is the device name listed in this FDA 510(k) record. The listed applicant is Kelsar Corp.. It received FDA 510(k) clearance on 1978-12-04 under 510(k) number K781987. The device is classified under product code KNY. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the URINARY DRAINAGE BAG?

URINARY DRAINAGE BAG is a medical device that received FDA 510(k) clearance on 1978-12-04. The listed applicant is Kelsar Corp.. The 510(k) number is K781987.

When did URINARY DRAINAGE BAG receive FDA 510(k) clearance?

URINARY DRAINAGE BAG received FDA 510(k) clearance on 1978-12-04, under 510(k) number K781987.

Who is the listed applicant for URINARY DRAINAGE BAG?

The FDA 510(k) record lists Kelsar Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for URINARY DRAINAGE BAG?

The FDA product code for URINARY DRAINAGE BAG is KNY.

Related Clinical Trials

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.

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Other records listing Kelsar Corp. 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.

K790005ADMINISTRATION SET, ENEMA

Related Devices (Code: KNY)

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.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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