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FDA 510(k)

URO-FLO

K-Number: K945140 · 1995-03-08

ApplicantMallinckrodt Group, Inc.
Decision Date1995-03-08
Product CodeLJH
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

URO-FLO is the device name listed in this FDA 510(k) record. The listed applicant is Mallinckrodt Group, Inc.. It received FDA 510(k) clearance on 1995-03-08 under 510(k) number K945140. The device is classified under product code LJH. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the URO-FLO?

URO-FLO is a medical device that received FDA 510(k) clearance on 1995-03-08. The listed applicant is Mallinckrodt Group, Inc.. The 510(k) number is K945140.

When did URO-FLO receive FDA 510(k) clearance?

URO-FLO received FDA 510(k) clearance on 1995-03-08, under 510(k) number K945140.

Who is the listed applicant for URO-FLO?

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

What is the FDA product code for URO-FLO?

The FDA product code for URO-FLO is LJH.

Other records listing Mallinckrodt Group, Inc. as applicant

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Related Devices (Code: LJH)

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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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