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FDA 510(k) Application Details - K003822
Device Classification Name
Appliance, Fixation, Spinal Interlaminal
More FDA Info for this Device
510(K) Number
K003822
Device Name
Appliance, Fixation, Spinal Interlaminal
Applicant
DEPUY ACROMED
325 PARAMOUNT DR.
RAYNHAM, MA 02767-0350 US
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Contact
FRANK MAAS
Other 510(k) Applications for this Contact
Regulation Number
888.3050
More FDA Info for this Regulation Number
Classification Product Code
KWP
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/11/2000
Decision Date
01/08/2001
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OR - Orthopedic
Review Advisory Committee
OR - Orthopedic
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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