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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 K130599
Device Name WART FREEZE
Applicant
Koninklijke Utermohlen NV
11956 Bernardo Plz. Dr.
#417
San Diego,  CA  92128
Applicant Contact KENNETH R MICHAEL
Correspondent
Koninklijke Utermohlen NV
11956 Bernardo Plz. Dr.
#417
San Diego,  CA  92128
Correspondent Contact KENNETH R MICHAEL
Regulation Number878.4350
Classification Product Code
GEH  
Date Received03/07/2013
Decision Date 06/05/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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