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FDA 510(k) Application Details - K180582
Device Classification Name
Cerclage, Fixation
More FDA Info for this Device
510(K) Number
K180582
Device Name
Cerclage, Fixation
Applicant
A & E Medical Corporation
5206 Asbury Road
Farmingdale, NJ 07727 US
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Contact
Hollie Johnson
Other 510(k) Applications for this Contact
Regulation Number
888.3010
More FDA Info for this Regulation Number
Classification Product Code
JDQ
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More FDA Info for this Product Code
Date Received
03/05/2018
Decision Date
05/31/2018
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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