CONSTRICTOR RING FOR PENILE ERECTION— 510(k) K891125

Name: FDA 510(k) clearance K891125
Creator: U.S. Food and Drug Administration
Published: 1989-04-27

Substantially Equivalent

Performance, Inc.

FDA 510(k) clearance K891125 for CONSTRICTOR RING FOR PENILE ERECTION, Substantially Equivalent on 1989-04-27. Applicant: Performance, Inc.. Device class: 2.

Clearance details

Applicant: Performance, Inc.
Product code: Code LKY
Device class: Class 2
Regulation: 21 CFR 876.5020
Advisory panel: Gastroenterology, Urology
Date received: 1989-03-03
Decision date: 1989-04-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Great Neck, NY, US

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