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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Unit, Cryophthalmic
510(k) Number K874555
Device Name KEELER ACU 22XT OPHTHALMIC CRYO UNIT
Applicant
Keeler Instruments, Inc.
456 Pkwy.
Broomall,  PA  19008
Applicant Contact VAN ARSDALE
Correspondent
Keeler Instruments, Inc.
456 Pkwy.
Broomall,  PA  19008
Correspondent Contact VAN ARSDALE
Regulation Number886.4170
Classification Product Code
HPS  
Date Received11/04/1987
Decision Date 01/29/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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