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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 Ste G
San Clemente,  CA  92673
Applicant Contact Al Memmolo
Correspondent
DALLEN MEDICAL, INC.
1046 Calle Recodo Ste 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
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