The following data is part of a premarket notification filed by Keller Instruments, Inc. with the FDA for Spembly 140 Cryosystem Probes & Tips.
| Device ID | K823835 |
| 510k Number | K823835 |
| Device Name: | SPEMBLY 140 CRYOSYSTEM PROBES & TIPS |
| Classification | Unit, Cryotherapy, Ophthalmic |
| Applicant | KELLER INSTRUMENTS, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | HQA |
| CFR Regulation Number | 886.4170 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-12-21 |
| Decision Date | 1983-01-17 |