FDA 510(k) Applications for Medical Device Product Code "FHA"
(Clamp, Penile)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K955810 | LABORIE MEDICAL TECHNOLOGIES, LTD. | U-TEX | 01/24/1996 |
| K970308 | MENTOR UROLOGY, INC. | MENTOR UROLOGY TRIPLE RIB OCCLUSION WRAP FOR MALE INCONTINENCE | 04/02/1997 |
| K964580 | NEBEL, INC. | CAP-AID (IMPROVED) | 01/10/1997 |
| K974040 | TIMM RESEARCH CO. | C3 EXTERNAL MALE BLADDER CONTROL DEVICE | 07/14/1998 |
| K971992 | UROMED CORP. | UROMED ALTERNATIVE BLADDER CONTROL CONTINENCE DEVICE(ABCPN-0026) | 08/01/1997 |
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