The following data is part of a premarket notification filed by Cook Ob/gyn with the FDA for Coaxial Catheter Set.
| Device ID | K902694 |
| 510k Number | K902694 |
| Device Name: | COAXIAL CATHETER SET |
| Classification | Cap, Cervical |
| Applicant | COOK OB/GYN 1100 WEST MORGAN ST. P.O. BOX 271 Spencer, IN 47460 |
| Contact | Michelle Young |
| Correspondent | Michelle Young COOK OB/GYN 1100 WEST MORGAN ST. P.O. BOX 271 Spencer, IN 47460 |
| Product Code | HDR |
| CFR Regulation Number | 884.5250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-06-19 |
| Decision Date | 1990-08-28 |