UROMED ALTERNATIVE BLADDER CONTROL CONTINENCE DEVICE(ABCPN-0026)— 510(k) K971992

Name: FDA 510(k) clearance K971992
Creator: U.S. Food and Drug Administration
Published: 1997-08-01

Substantially Equivalent

Uromed Corp.

FDA 510(k) clearance K971992 for UROMED ALTERNATIVE BLADDER CONTROL CONTINENCE DEVICE(ABCPN-0026), Substantially Equivalent on 1997-08-01. Applicant: Uromed Corp.. Device class: 1.

Clearance details

Applicant: Uromed Corp.
Product code: Code FHA
Device class: Class 1
Regulation: 21 CFR 876.5160
Advisory panel: Gastroenterology, Urology
Date received: 1997-05-29
Decision date: 1997-08-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Needham, MA, US

Download summary PDF View on FDA.gov ↗

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