SURGITEK ERECTEK TM EXTERNAL ERECTION DEVICE— 510(k) K905015

Name: FDA 510(k) clearance K905015
Creator: U.S. Food and Drug Administration
Published: 1990-12-28

Substantially Equivalent

Surgitek

FDA 510(k) clearance K905015 for SURGITEK ERECTEK TM EXTERNAL ERECTION DEVICE, Substantially Equivalent on 1990-12-28. Applicant: Surgitek. Device class: 2.

Clearance details

Applicant: Surgitek
Product code: Code LKY
Device class: Class 2
Regulation: 21 CFR 876.5020
Advisory panel: Gastroenterology, Urology
Date received: 1990-11-07
Decision date: 1990-12-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Racine, WI, US

Download summary PDF View on FDA.gov ↗

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