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FDA 510(k) Application Details - K991862
Device Classification Name
Orthosis, Spinal Pedicle Fixation
More FDA Info for this Device
510(K) Number
K991862
Device Name
Orthosis, Spinal Pedicle Fixation
Applicant
MICOMED GMBH
511 CATALINA RD.
FULLERTON, CA 92835 US
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Contact
CHARMAINE HENDERSON
Other 510(k) Applications for this Contact
Regulation Number
888.3070
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Classification Product Code
MNI
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More FDA Info for this Product Code
Date Received
06/01/1999
Decision Date
01/13/2000
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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