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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
342 E. Main St.
Suite 211
Leola,  PA  17540
Applicant Contact WILLIAM G MCLAIN
Correspondent
Kema Quality B.V.
4377 County Line Rd.
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
Predetermined Change
Control Plan Authorized		 No
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