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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 K131839
Device Name DC 7
Applicant
Dc International, LLC
624 Cypress Green Cir.
Wellington,  FL  33414
Applicant Contact DAVID BOEGLER
Correspondent
Dc International, LLC
624 Cypress Green Cir.
Wellington,  FL  33414
Correspondent Contact DAVID BOEGLER
Regulation Number878.4810
Classification Product Code
GEX  
Date Received06/21/2013
Decision Date 11/07/2013
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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