The following data is part of a premarket notification filed by Keeler Instruments, Inc. with the FDA for Series 25 Slimline Cryo Probes.
| Device ID | K854422 |
| 510k Number | K854422 |
| Device Name: | SERIES 25 SLIMLINE CRYO PROBES |
| Classification | Unit, Cryotherapy, 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 | HQA |
| CFR Regulation Number | 886.4170 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-11-04 |
| Decision Date | 1985-12-30 |