The following data is part of a premarket notification filed by Keeler Instruments, Inc. with the FDA for Thorton Titanium Needleholders(no,w Catch & Stand.
| Device ID | K863991 |
| 510k Number | K863991 |
| Device Name: | THORTON TITANIUM NEEDLEHOLDERS(NO,W CATCH & STAND |
| Classification | Forceps, Ophthalmic |
| Applicant | KEELER INSTRUMENTS, INC. 456 PKWY. Broomall, PA 19008 |
| Contact | Van Arsdale |
| Correspondent | Van Arsdale KEELER INSTRUMENTS, INC. 456 PKWY. Broomall, PA 19008 |
| Product Code | HNR |
| CFR Regulation Number | 886.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-10-14 |
| Decision Date | 1986-10-31 |