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FDA 510(k) Application Details - K942032
Device Classification Name
Plate, Fixation, Bone
More FDA Info for this Device
510(K) Number
K942032
Device Name
Plate, Fixation, Bone
Applicant
HOSPITAL FOR SPECIAL SURGERY
535 EAST 70TH ST.
NEW YORK, NY 10021 US
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Contact
BRUCE H ROBIE
Other 510(k) Applications for this Contact
Regulation Number
888.3030
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Classification Product Code
HRS
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More FDA Info for this Product Code
Date Received
04/26/1994
Decision Date
06/13/1996
Decision
SN - Substantially Equivalent for Some Indications
Classification Advisory Committee
OR - Orthopedic
Review Advisory Committee
OR - Orthopedic
Statement / Summary / Purged Status
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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