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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Unit, Cryosurgical, Accessories
510(k) Number K152203
Device Name UTERMOHLEN CRYO PROFESSIONAL
Applicant
Koninklijke (Royal) Utermohlen
Dee Overweg 1
Wolvega,  NL 8471ZA
Applicant Contact MR.D VAN HOOF
Correspondent
Krm Associates
17751 Frondosa Dr.
San Diego,  CA  92128
Correspondent Contact DR K R MICHAEL
Regulation Number878.4350
Classification Product Code
GEH  
Date Received08/06/2015
Decision Date 11/06/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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