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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Powered Laser Surgical Instrument
510(k) Number K052310
Device Name CRYOFLOW 700, CRYOFLOW 1000
Applicant
Uniphy Elektromedizin GmbH & Co. KG
6a Pasweg
Bilzen,  BE 3740
Applicant Contact NICO BEUN
Correspondent
Uniphy Elektromedizin GmbH & Co. KG
6a Pasweg
Bilzen,  BE 3740
Correspondent Contact NICO BEUN
Regulation Number878.4810
Classification Product Code
GEX  
Date Received08/24/2005
Decision Date 03/15/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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