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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Light, Surgical, Fiberoptic
510(k) Number K955510
Device Name X6000D SILENT SUN LIGHT SOURCE
Applicant
Products For Medicine
3722 Ave. Sausalito
Irvine,  CA  92714
Applicant Contact GREG HOLLAND
Correspondent
Products For Medicine
3722 Ave. Sausalito
Irvine,  CA  92714
Correspondent Contact GREG HOLLAND
Regulation Number878.4580
Classification Product Code
FST  
Subsequent Product Codes
FFS   HBI  
Date Received12/04/1995
Decision Date 01/31/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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