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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, Ac-Powered
510(k) Number K112093
Device Name CRYOMATIC CRYO CONSOLE, DISPOSABLE CRYO PROBE, DISPOSABLE PROBE ADAPTER
Applicant
Keeler Instruments, Inc.
456 Pkwy.
Broomall,  PA  19008
Applicant Contact EUGENE R VANARSDALE
Correspondent
Keeler Instruments, Inc.
456 Pkwy.
Broomall,  PA  19008
Correspondent Contact EUGENE R VANARSDALE
Regulation Number886.4170
Classification Product Code
HRN  
Date Received07/22/2011
Decision Date 12/08/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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