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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 K143092
Device Name Tensyn Plug
Applicant
Dallen Medical, Inc.
1046 Calle Recodo, Suite G
San Clemente,  CA  92673
Applicant Contact Al Memmolo
Correspondent
Dallen Medical, Inc.
1046 Calle Recodo, Suite G
San Clemente,  CA  92673
Correspondent Contact Al Memmolo
Regulation Number888.3030
Classification Product Code
HTN  
Date Received10/28/2014
Decision Date 02/11/2015
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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