The following data is part of a premarket notification filed by Keeler Optical Products Ltd. with the FDA for Keeler Amoils Acull Cryo Ophthalmic Unit.
| Device ID | K801418 |
| 510k Number | K801418 |
| Device Name: | KEELER AMOILS ACULL CRYO OPHTHALMIC UNIT |
| Classification | Unit, Cryophthalmic |
| Applicant | KEELER OPTICAL PRODUCTS LTD. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | HPS |
| CFR Regulation Number | 886.4170 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-06-17 |
| Decision Date | 1980-07-21 |