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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 K014253
Device Name DERMACHILLER 4
Applicant
Paradigm Trex, LLC
10455 Pacific Center Ct.
San Diego,  CA  92121 -4339
Applicant Contact NIKOLAI TANKOVICH
Correspondent
Paradigm Trex, LLC
10455 Pacific Center Ct.
San Diego,  CA  92121 -4339
Correspondent Contact NIKOLAI TANKOVICH
Regulation Number878.4810
Classification Product Code
GEX  
Date Received12/26/2001
Decision Date 03/26/2002
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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