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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 K113330
Device Name CABLECAP
Applicant
Sensormed
2450 Ej Chapman Dr.,
Knoxville,  TN  37996
Applicant Contact WILLIAM MILAM
Correspondent
Sensormed
2450 Ej Chapman Dr.,
Knoxville,  TN  37996
Correspondent Contact WILLIAM MILAM
Regulation Number878.4580
Classification Product Code
FST  
Date Received11/14/2011
Decision Date 01/12/2012
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
Predetermined Change
Control Plan Authorized		 No
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