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FDA 510(k) Application Details - K972327
Device Classification Name
Cerclage, Fixation
More FDA Info for this Device
510(K) Number
K972327
Device Name
Cerclage, Fixation
Applicant
PACIFIC MATERIALS AND INTERFACES
4329 GRAYDON RD.
SAN DIEGO, CA 92130 US
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Contact
FLOYD G LARSON
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
06/23/1997
Decision Date
08/11/1997
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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