REJOYN PENILE SUPPORT SYSTEM— 510(k) K971576

Substantially Equivalent

American Medtech

FDA 510(k) clearance K971576 for REJOYN PENILE SUPPORT SYSTEM, Substantially Equivalent on 1997-10-16. Applicant: American Medtech. Device class: 2.

Clearance details

Applicant: American Medtech
Product code: Code LKY
Device class: Class 2
Regulation: 21 CFR 876.5020
Advisory panel: Gastroenterology, Urology
Date received: 1997-04-25
Decision date: 1997-10-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, US

Download summary PDF View on FDA.gov ↗

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K013113 — MODIFICATION TO NANMA VACUUM PUMP2002-12-20

Data sourced from openFDA. This site is unofficial and independent of the FDA.