The following data is part of a premarket notification filed by Simpson/basye, Inc. with the FDA for Campion Cervical Hook.
| Device ID | K891349 |
| 510k Number | K891349 |
| Device Name: | CAMPION CERVICAL HOOK |
| Classification | Tenaculum, Uterine |
| Applicant | SIMPSON/BASYE, INC. 430 AYRE ST. Wilmington, DE 19804 |
| Contact | Robert A Basye |
| Correspondent | Robert A Basye SIMPSON/BASYE, INC. 430 AYRE ST. Wilmington, DE 19804 |
| Product Code | HDC |
| CFR Regulation Number | 884.4530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-03-10 |
| Decision Date | 1989-03-29 |