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

Substantially Equivalent

Surgitek

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

Clearance details

Applicant
Surgitek
Product code
Code LKY
Advisory panel
Gastroenterology, Urology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Racine, WI, US
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