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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, Ceiling Mounted
510(k) Number K132551
Device Name ZF 720
Applicant
UMBEL CORPORATION
2339 CANYON PARK DR.
DIAMOND BAR,  CA  91765
Applicant Contact HAYDEN WOOD
Correspondent
UMBEL CORPORATION
2339 CANYON PARK DR.
DIAMOND BAR,  CA  91765
Correspondent Contact HAYDEN WOOD
Regulation Number878.4580
Classification Product Code
FSY  
Date Received08/14/2013
Decision Date 06/30/2014
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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