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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 K133425
Device Name SCINTILLANT DUAL BENT TIP SURGICAL LIGHT, SCINTILLANT DUAL STRAIGHT TIP SURGICAL LIGHT
Applicant
Engineered Medical Solutions Co., LLC
85 Industrial Dr.
Bldg. B
Phillipsburg,  NJ  08865
Applicant Contact RYAN SAVAGE
Correspondent
Engineered Medical Solutions Co., LLC
85 Industrial Dr.
Bldg. B
Phillipsburg,  NJ  08865
Correspondent Contact RYAN SAVAGE
Regulation Number878.4580
Classification Product Code
FTD  
Date Received11/08/2013
Decision Date 12/05/2013
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
Predetermined Change
Control Plan Authorized		 No
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