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FDA 510(k) Application Details - K960651
Device Classification Name
Cerclage, Fixation
More FDA Info for this Device
510(K) Number
K960651
Device Name
Cerclage, Fixation
Applicant
ACU-MED, INC.
10950 SW 5TH, SUITE 170
BEAVETON, OR 97005 US
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Contact
SHARI L JEFFERS
Other 510(k) Applications for this Contact
Regulation Number
888.3010
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Classification Product Code
JDQ
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More FDA Info for this Product Code
Date Received
02/15/1996
Decision Date
05/03/1996
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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