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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 K122871
Device Name COMPRESSYN STAPLE
Applicant
DALLEN MEDICAL, INC.
1046 calle recodo ste g
san clemente,  CA  92673
Contact al memmolo
Regulation Number888.3030
Classification Product Code
JDR  
Date Received09/19/2012
Decision Date 02/07/2013
Decision substantially equivalent (SE)
Classification Advisory Committee Orthopedic
Review Advisory Committee Orthopedic
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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