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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 K071883
Device Name IPULSE, QUADRA Q4 PLATINUM SERIES, MODEL(S) 1200+SERIES 2, 1300 SERIES 2, Q4 SERIES 2
Applicant
CYDEN LIMITED
TECHNIUM 1, KINGS ROAD
SWANSEA, WALES,  GB SA1 8PH
Applicant Contact MICHAEL KIERNAN
Correspondent
CYDEN LIMITED
TECHNIUM 1, KINGS ROAD
SWANSEA, WALES,  GB SA1 8PH
Correspondent Contact MICHAEL KIERNAN
Regulation Number878.4810
Classification Product Code
GEX  
Date Received07/09/2007
Decision Date 01/23/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
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