The following data is part of a premarket notification filed by Keeler Instruments, Inc. with the FDA for Thornton Titanium Forceps (various Types).
Device ID | K863992 |
510k Number | K863992 |
Device Name: | THORNTON TITANIUM FORCEPS (VARIOUS TYPES) |
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 |