The following data is part of a premarket notification filed by Cook Urological, Inc. with the FDA for Insemi-cath Ii.
| Device ID | K954398 |
| 510k Number | K954398 |
| Device Name: | INSEMI-CATH II |
| Classification | Cannula, Intrauterine Insemination |
| Applicant | COOK UROLOGICAL, INC. 1100 WEST MORGAN ST. P.O. BOX 227 Spencer, IN 47460 |
| Contact | Tammy Bacon |
| Correspondent | Tammy Bacon COOK UROLOGICAL, INC. 1100 WEST MORGAN ST. P.O. BOX 227 Spencer, IN 47460 |
| Product Code | MFD |
| CFR Regulation Number | 884.5250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-09-20 |
| Decision Date | 1995-12-19 |