The following data is part of a premarket notification filed by Timm Research Co. with the FDA for C3 External Male Bladder Control Device.
| Device ID | K974040 |
| 510k Number | K974040 |
| Device Name: | C3 EXTERNAL MALE BLADDER CONTROL DEVICE |
| Classification | Clamp, Penile |
| Applicant | TIMM RESEARCH CO. 6541 CITY WEST PKWY. Eden Prairie, MN 55344 |
| Contact | David Anderson |
| Correspondent | David Anderson TIMM RESEARCH CO. 6541 CITY WEST PKWY. Eden Prairie, MN 55344 |
| Product Code | FHA |
| CFR Regulation Number | 876.5160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-10-24 |
| Decision Date | 1998-07-14 |
| Summary: | summary |