The following data is part of a premarket notification filed by Keeler Instruments, Inc. with the FDA for Cryophthalmic Unit.
| Device ID | K811244 |
| 510k Number | K811244 |
| Device Name: | CRYOPHTHALMIC UNIT |
| Classification | Plate, Fixation, Bone |
| Applicant | KEELER INSTRUMENTS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-05-04 |
| Decision Date | 1981-06-23 |