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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 K141330
Device Name ENDO-CORD
Applicant
Enroxtech, Inc.
4655 Kirkwood Court
Boulder,  CO  80301
Applicant Contact LEWIS WARD
Correspondent
Enroxtech, Inc.
4655 Kirkwood Court
Boulder,  CO  80301
Correspondent Contact LEWIS WARD
Regulation Number878.4580
Classification Product Code
FST  
Date Received05/21/2014
Decision Date 12/15/2014
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
Predetermined Change
Control Plan Authorized		 No
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