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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 K130256
Device Name MDK MULTI-APPLICATIONS PLATFORM
Applicant
Quanta System Spa
Via Iv Novembre, 116
Solbiate Olona (Va),  IT 21058
Applicant Contact Maurizio Bianchi
Correspondent
Quanta System Spa
Via Iv Novembre, 116
Solbiate Olona (Va),  IT 21058
Correspondent Contact Maurizio Bianchi
Regulation Number878.4810
Classification Product Code
GEX  
Date Received02/01/2013
Decision Date 07/02/2013
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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