The following data is part of a premarket notification filed by Towne Brothers (pvt.), Ltd. with the FDA for Uterine Tenaclum Hook.
| Device ID | K001818 |
| 510k Number | K001818 |
| Device Name: | UTERINE TENACLUM HOOK |
| Classification | Tenaculum, Uterine |
| Applicant | TOWNE BROTHERS (PVT.), LTD. 52-B INDUSTRIAL ESTATE P.O. BOX 108 Sialkot, PK 51310 |
| Contact | Abdul Ghafoor |
| Correspondent | Abdul Ghafoor TOWNE BROTHERS (PVT.), LTD. 52-B INDUSTRIAL ESTATE P.O. BOX 108 Sialkot, PK 51310 |
| Product Code | HDC |
| CFR Regulation Number | 884.4530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-06-15 |
| Decision Date | 2000-08-30 |