THE PERFORMANCE PLUS CONFIDENCE RINGS, THE PERFORMANCE PLUS ERECTION INDUCER DEVICE— 510(k) K974082

Name: FDA 510(k) clearance K974082
Creator: U.S. Food and Drug Administration
Published: 1998-02-27

Substantially Equivalent

Performance Plus, Inc.

FDA 510(k) clearance K974082 for THE PERFORMANCE PLUS CONFIDENCE RINGS, THE PERFORMANCE PLUS ERECTION INDUCER DEVICE, Substantially Equivalent on 1998-02-27. Applicant: Performance Plus, Inc.. Device class: 2.

Clearance details

Applicant: Performance Plus, Inc.
Product code: Code LKY
Device class: Class 2
Regulation: 21 CFR 876.5020
Advisory panel: Gastroenterology, Urology
Date received: 1997-10-29
Decision date: 1998-02-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Great Neck, NY, US

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