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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Staple, Fixation, Bone
510(k) Number K140358
Device Name COMPRESSYN STAPLE
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
JDR  
Date Received02/12/2014
Decision Date 06/02/2014
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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