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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 K012214
Device Name CRYOPEN AND ACCESSORIES
Applicant
Cimex Biotech, LLC
72385 Industry Park
Covington,  LA  70435
Applicant Contact MICHAEL HAAS
Correspondent
Cimex Biotech, LLC
72385 Industry Park
Covington,  LA  70435
Correspondent Contact MICHAEL HAAS
Regulation Number878.4350
Classification Product Code
GEH  
Date Received07/16/2001
Decision Date 04/26/2002
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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