FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
POS-T-VAC B-10 BAND KIT
K Number: K960828
·
Decision Mar 8, 1996
Classifications
1
FEI Numbers
51
Registration Numbers
51
Same Product Code
86
Applicant Total
12
Review Days
8
Basic Information
- Device Name
- POS-T-VAC B-10 BAND KIT
- K Number
- K960828
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5020
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- POS-T-VAC, INC.
- Date Received
- February 29, 1996
- Decision Date
- March 8, 1996
- Product Code
- LKY
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| LKY | Device, External Penile Rigidity | FDA class 2 | Gastroenterology, Urology |
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Other Clearances by POS-T-VAC, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K020154 | VT-1 | Apr 4, 2002 | Substantially Equivalent |
| K020258 | SUPPORT SLEEVE | Apr 4, 2002 | Substantially Equivalent |
| K012670 | BOSS 2000-3 VACUUM ERECTION DEVICE | Nov 9, 2001 | Substantially Equivalent |
| K012672 | BOSS-2000-2 VACUUM ERECTION DEVICE | Nov 9, 2001 | Substantially Equivalent |
| K983246 | POS-T-VAC (IVP-600) | Nov 2, 1998 | Substantially Equivalent |
| K983245 | POS-T-VAC (AVP-1000) | Nov 2, 1998 | Substantially Equivalent |
| K981180 | REJOYN CONSTRICTION RING KIT, POS-T-VAC B-100 RING KIT, POS-T-VAC B-25 RING KIT AND POS-T-VAC B-10 RING KIT | Aug 28, 1998 | Substantially Equivalent |
| K981011 | POS-T-VAC (REJOYN VACUUM ERECTION DEVICE) | Aug 28, 1998 | Substantially Equivalent |
| K961309 | POS-T-VAC ID-300 | Jun 10, 1996 | Substantially Equivalent |
| K960342 | POS-T-VAC AVP-1000 & MVP-700 | Mar 1, 1996 | Substantially Equivalent |