510(k) K974196
- Device
- MEGAVAC SYSTEM
- Applicant
- BARRY J. KAPLAN, INC.
- 510(k) number
- K974196
- Product code
- LKY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1998-05-12
- Date received
- 1997-11-07
- Regulation
- 876.5020
- Classification name
- Device, External Penile Rigidity
- Medical specialty
- Gastroenterology/Urology
- Review panel
- Gastroenterology/Urology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- BARRY J KAPLAN
- Address
- 1286 University Ave., Suite 221 San Diego CA US 92103 92103
FDA Registration Numbers#
- 3014686987
- 3010458645
- 3015200846
- 3007962592
- 2531449
- 3011015568
- 1058602
- 3017552081
- 1931563
- 8021764
- 3013143994
- 3010386378
- 3003865243
- 3008487461
- 3033790325
- 3025376109
- 2433231
- 3009722622
- 3003071219
- 3017264244
- 9616086
- 1527982
- 3010832019
- 3014326210
- 3006317264
- 3016028125
- 3012110942
- 3016159407
- 2031447
- 3014159402
- 3026849514
- 3042194079
- 1065838
- 3003348846
- 3042023384
- 3010031846
- 1932668
- 3023140863
- 3009129782
- 3029906446
- 3011821164
- 3010251578
- 3010849337
- 3042276479
- 3011014178
- 3026270764
- 3009134882
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code LKY #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K041573 | NANMA VACUUM PUMP PROXZEK MODEL 2M9498S | Nanma Mfg Co., Ltd. | 2004-08-25 |
| K032776 | VACURECT VACUUM CONSTRICTION DEVICE | Vacurect Manufacturing (Pty) , Ltd. | 2003-10-03 |
| K030119 | NANMA ADJUSTABLE CONSTRICTION RING | Nanma Mfg Co., Ltd. | 2003-08-06 |
| K030913 | NANMA VACUUM PUMP | Nanma Mfg Co., Ltd. | 2003-06-03 |
| K013113 | MODIFICATION TO NANMA VACUUM PUMP | Nanma Mfg Co., Ltd. | 2002-12-20 |
| K013051 | NANMA ADJUSTABLE CONSTRICTION RING | Nanma Mfg Co., Ltd. | 2002-08-22 |
| K020969 | VACURECT VACUUM CONSTRICTION DEVICE | Vacurect Manufacturing (Pty) , Ltd. | 2002-06-05 |
| K013053 | MODIFICATION TO NANMA NON-ADJUSTABLE CONSTRICTION RING | Nanma Mfg Co., Ltd. | 2002-05-09 |
| K020154 | VT-1 | Pos-T-Vac, Inc. | 2002-04-04 |
| K020258 | SUPPORT SLEEVE | Pos-T-Vac, Inc. | 2002-04-04 |
| K020082 | ERECAID CLASSIC SYSTEM; ERECAID ESTEEM MANUAL SYSTEM; ERECAID ESTEEM BATTERY SYSTEM | Endocare, Inc. | 2002-02-05 |
| K012639 | SE-300 VACUUM THERAPY SYSTEM | Vts, Inc. | 2001-11-09 |
| K012662 | SE-100 VACUUM ERECTION DEVICE | Vts, Inc. | 2001-11-09 |
| K012670 | BOSS 2000-3 VACUUM ERECTION DEVICE | Pos-T-Vac, Inc. | 2001-11-09 |
| K012672 | BOSS-2000-2 VACUUM ERECTION DEVICE | Pos-T-Vac, Inc. | 2001-11-09 |
Legacy Summary#
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FDA Review#
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