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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Lamp, Operating-Room
510(k) Number K993314
Device Name SYNTHES LIGHT GUIDE
Applicant
Synthes (Usa)
1303 Goshen Pkwy.
West Chester,  PA  19380
Applicant Contact JONATHAN GILBERT
Correspondent
Synthes (Usa)
1303 Goshen Pkwy.
West Chester,  PA  19380
Correspondent Contact JONATHAN GILBERT
Regulation Number878.4580
Classification Product Code
FQP  
Date Received10/04/1999
Decision Date 12/06/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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