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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name lamp, surgical
510(k) Number K130513
Device Name VOLISTA 400; VOLISTA 600
Applicant
MAQUET SAS
45 BARBOUR POND DRIVE
WAYNE,  NJ  07470
Applicant Contact TOSIN YEDESS
Correspondent
MAQUET SAS
45 BARBOUR POND DRIVE
WAYNE,  NJ  07470
Correspondent Contact TOSIN YEDESS
Regulation Number878.4580
Classification Product Code
FTD  
Subsequent Product Code
FSY  
Date Received02/27/2013
Decision Date 05/08/2013
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
Recalls CDRH Recalls
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