The following data is part of a premarket notification filed by Onli with the FDA for Obsti-hook.
| Device ID | K951148 |
| 510k Number | K951148 |
| Device Name: | OBSTI-HOOK |
| Classification | Amniotome |
| Applicant | ONLI 506 WICKHAM WAY Gahanna, OH 43230 |
| Contact | Charles T Sampson, Iii |
| Correspondent | Charles T Sampson, Iii ONLI 506 WICKHAM WAY Gahanna, OH 43230 |
| Product Code | HGE |
| CFR Regulation Number | 884.4530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-03-13 |
| Decision Date | 1995-06-09 |