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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 K071180
Device Name SCINTILLANT SURGICAL LIGHT, MODEL 2644-01-0001
Applicant
ENGINEERED MEDICAL SOLUTIONS CO. LLC
342E. MAIN STREET, SUITE 211
LEOLA,  PA  17540
Applicant Contact WILLIAM G MCLAIN
Correspondent
KEMA QUALITY B.V.
4377 COUNTY LINE ROAD
CHALFONT,  PA  18914
Correspondent Contact PATRICIA L MURPHY
Regulation Number878.4580
Classification Product Code
FTD  
Date Received04/30/2007
Decision Date 06/20/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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