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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 K936048
Device Name LIGHTWEAR(TM) SYST (LIGHTWEAR HEADLIGHT CLIP/HEADBAND)
Applicant
COGENT LIGHT TECHNOLOGIES, INC.
26145 TECHNOLOGY DR.
SANTA CLARITA,  CA  91355 -1137
Applicant Contact ENID ROKAS
Correspondent
COGENT LIGHT TECHNOLOGIES, INC.
26145 TECHNOLOGY DR.
SANTA CLARITA,  CA  91355 -1137
Correspondent Contact ENID ROKAS
Regulation Number878.4580
Classification Product Code
FST  
Subsequent Product Code
FSQ  
Date Received12/20/1993
Decision Date 03/10/1994
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
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