KEELER AMOILS ACULL CRYO OPHTHALMIC UNIT

Unit, Cryophthalmic

KEELER OPTICAL PRODUCTS LTD.

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.

Pre-market Notification Details

Device IDK801418
510k NumberK801418
Device Name:KEELER AMOILS ACULL CRYO OPHTHALMIC UNIT
ClassificationUnit, Cryophthalmic
Applicant KEELER OPTICAL PRODUCTS LTD. 4221 Richmond Rd., N.W. Walker,  MI  49534
Product CodeHPS  
CFR Regulation Number886.4170 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1980-06-17
Decision Date1980-07-21

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