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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, accessories
510(k) Number K142386
Device Name Operating Room Light Handle Adapter
Applicant
Litex Manufacturing, Inc.
1501 Sunshine Drive
Glendale,  CA  91208
Applicant Contact Noel Gharibian
Correspondent
ADVANCED MEDICAL INNOVATIONS
8741 Shirley Ave
Northridge,  CA  91324
Correspondent Contact MIKE HOFTMAN
Regulation Number878.4580
Classification Product Code
FTA  
Date Received08/27/2014
Decision Date 09/29/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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