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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 K131473
Device Name (QUANTA SYSTEM) SURGICAL LASER FIBERS
Applicant
QUANTA SYSTEM, S.P.A.
VIA IV NOVEMBRE,116
SOLBIATE OLONA,  IT 21058
Applicant Contact Maurizio Bianchi
Correspondent
QUANTA SYSTEM, S.P.A.
VIA IV NOVEMBRE,116
SOLBIATE OLONA,  IT 21058
Correspondent Contact Maurizio Bianchi
Regulation Number878.4810
Classification Product Code
GEX  
Date Received05/22/2013
Decision Date 10/24/2013
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
Recalls CDRH Recalls
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