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 |