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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 K160513
Device Name Quanta System Surgical Laser fibers
Applicant
Quanta System Spa
Via Iv Novembre, 116
Solbiate Olona (Va),  IT 21058
Applicant Contact FRANCESCO DELL'ANTONIO
Correspondent
Quanta System Spa
Via Iv Novembre, 116
Solbiate Olona (Va),  IT 21058
Correspondent Contact FRANCESCO DELL'ANTONIO
Regulation Number878.4810
Classification Product Code
GEX  
Date Received02/24/2016
Decision Date 03/18/2016
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
Recalls CDRH Recalls
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