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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Washer, Bolt Nut
510(k) Number K111032
Device Name CMC CABLE FIX
Applicant
Instratek, Inc.
4141 Directors Row
Suite H
Houston,  TX  77092
Applicant Contact Jeff Seavey
Correspondent
Instratek, Inc.
4141 Directors Row
Suite H
Houston,  TX  77092
Correspondent Contact Jeff Seavey
Regulation Number888.3030
Classification Product Code
HTN  
Date Received04/13/2011
Decision Date 08/31/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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