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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 K131787
Device Name CRYOMATIC MKII CONSOLE, CRYOMATIC MKII PROBES, DISPOSABLE CRYO PROBES
Applicant
Keeler, Ltd.
456 Pkwy.
Broomall,  PA  19008
Applicant Contact EUGENE R VANARSDALE
Correspondent
Keeler, Ltd.
456 Pkwy.
Broomall,  PA  19008
Correspondent Contact EUGENE R VANARSDALE
Regulation Number886.4170
Classification Product Code
HRN  
Date Received06/18/2013
Decision Date 12/23/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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