The following data is part of a premarket notification filed by Cook Ob/gyn with the FDA for Tubal Lumen Support.
| Device ID | K932114 |
| 510k Number | K932114 |
| Device Name: | TUBAL LUMEN SUPPORT |
| Classification | Prosthesis, Fallopian Tube |
| Applicant | COOK OB/GYN 1100 WEST MORGAN ST. P.O. BOX 271 Spencer, IN 47460 |
| Contact | Tammy Bacon |
| Correspondent | Tammy Bacon COOK OB/GYN 1100 WEST MORGAN ST. P.O. BOX 271 Spencer, IN 47460 |
| Product Code | HFJ |
| CFR Regulation Number | 884.3650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-05-03 |
| Decision Date | 1994-09-27 |
| Summary: | summary |