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FDA 510(k) Application Details - K101484
Device Classification Name
Cerclage, Fixation
More FDA Info for this Device
510(K) Number
K101484
Device Name
Cerclage, Fixation
Applicant
DALLEN MEDICAL
1046 CALLE RECODO
SUITE G
SAN CLEMENTE, CA 92673 US
Other 510(k) Applications for this Company
Contact
AL MEMMOLO
Other 510(k) Applications for this Contact
Regulation Number
888.3010
More FDA Info for this Regulation Number
Classification Product Code
JDQ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
05/28/2010
Decision Date
04/01/2011
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OR - Orthopedic
Review Advisory Committee
OR - Orthopedic
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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