510(k) K964580
- Device
- Cap-aid (improved)
- Applicant
- NEBEL, INC.
- 510(k) number
- K964580
- Product code
- FHA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1997-01-10
- Date received
- 1996-11-15
- Regulation
- 876.5160
- Classification name
- Clamp, Penile
- Medical specialty
- Gastroenterology, Urology
- Review panel
- Gastroenterology, Urology
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- JEFFREY A DANN, M.D.
- Address
- 44 Ter. Dr. Worcester MA US 01609 01609
FDA Registration Numbers#
- 3014334038
- 3013654075
- 3023657851
- 9611112
- 1932668
- 3002807115
- 3011014178
- 1825146
- 3005809810
- 9710524
- 1018233
- 2431166
- 3011137372
- 1646747
- 3013731289
- 3005067367
- 3006554912
- 1421879
- 9611102
- 3021815
- 3004001706
- 9617744
- 1651252
- 1836161
- 8040278
- 8010099
- 3010041511
- 3035678069
- 3029082594
- 1923569
- 3005987240
- 8040233
- 3014615697
- 2916714
- 3008770252
- 1123010
- 3003644849
- 9611283
- 9680518
- 9611590
- 2529846
- 3013548509
- 3016965929
- 9612074
- 3001644167
- 1820334
- 3010011359
- 9680718
- 3043842098
- 3010875172
- 3010399422
- 3016096126
- 9616246
- 9680519
- 8030607
- 9611503
- 3003244954
- 3022862651
- 3003418325
- 3004967086
- 3015895045
- 3005528784
- 3018514192
- 8010665
- 9610612
- 3008724689
- 3007222388
- 3004365956
- 3003622638
- 3009513193
Source Documents#
Other 510(k) Records For Product Code FHA#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K974040 | C3 EXTERNAL MALE BLADDER CONTROL DEVICE | Timm Research Co. | 1998-07-14 |
| K971992 | UROMED ALTERNATIVE BLADDER CONTROL CONTINENCE DEVICE(ABCPN-0026) | Uromed Corp. | 1997-08-01 |
| K970308 | MENTOR UROLOGY TRIPLE RIB OCCLUSION WRAP FOR MALE INCONTINENCE | Mentor Urology, Inc. | 1997-04-02 |
| K955810 | U-TEX | Laborie Medical Technologies, Ltd. | 1996-01-24 |
| K954959 | CAP-AID | Nebl, Inc. | 1995-12-06 |
| K952841 | THE ASSISTANT | Apple Medical Corp. | 1995-08-18 |
| K896160 | WILLIAMS PENILE ANESTHETIC RETAINER | Cook Urological, Inc. | 1990-02-16 |
| K885323 | DACOMED EXTERNAL MALE CONTINENCE DEVICE | Dacomed Corp. | 1989-02-08 |
| K863227 | COOK-VPI CONTINENCE CUFF | Cook Urological, Inc. | 1987-02-03 |
| K780137 | CLAMP, INCONTINENCE, BAUMRUCKER | Greenwald Surgical Co., Inc. | 1978-04-28 |