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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cord, Retraction
510(k) Number K091380
Device Name CORDCAP
Applicant
Centrix, Inc.
770 River Rd.
Shelton,  CT  06484 -5458
Applicant Contact JOHN DISCKO
Correspondent
Centrix, Inc.
770 River Rd.
Shelton,  CT  06484 -5458
Correspondent Contact JOHN DISCKO
Classification Product Code
MVL  
Date Received05/11/2009
Decision Date 07/30/2009
Decision Substantially Equivalent (SESE)
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product Yes
Predetermined Change
Control Plan Authorized		 No
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