The following data is part of a premarket notification filed by Keeler Instruments, Inc. with the FDA for Vickers Ergomatic Microsur Instru-univ R O L Hand.
| Device ID | K853179 |
| 510k Number | K853179 |
| Device Name: | VICKERS ERGOMATIC MICROSUR INSTRU-UNIV R O L HAND |
| Classification | Instrument, Microsurgical |
| 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 | GZX |
| CFR Regulation Number | 882.4525 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-07-30 |
| Decision Date | 1985-11-07 |