FDA 510(k), K012670, BOSS 2000-3 VACUUM ERECTION DEVICE

510(K) Number: K012670
Device Name: BOSS 2000-3 VACUUM ERECTION DEVICE
Manufacturer: POS-T-VAC, INC.
Device Classification Name: device, external penile rigidity
Regulation Number: 876.5020
Classification Product Code: LKY
Date Received: 08/13/2001
Decision Date: 11/09/2001
Regulation Medical Specialty: Gastroenterology/Urology

Total pages: 47
Fully redacted pages: 4
Content pages: 43