BOSS-2000-2 VACUUM ERECTION DEVICE— 510(k) K012672
Substantially EquivalentPos-T-Vac, Inc.
FDA 510(k) clearance K012672 for BOSS-2000-2 VACUUM ERECTION DEVICE, Substantially Equivalent on 2001-11-09. Applicant: Pos-T-Vac, Inc.. Device class: 2.
Clearance details
- Applicant
- Pos-T-Vac, Inc.
- Product code
- Code LKY
- Device class
- Class 2
- Regulation
- 21 CFR 876.5020
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Dodge City, KS, US
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