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FDA 510(k) Application Details - K994022
Device Classification Name
Methyl Methacrylate For Cranioplasty
More FDA Info for this Device
510(K) Number
K994022
Device Name
Methyl Methacrylate For Cranioplasty
Applicant
PARALLAX MEDICAL, INC.
453 RAVENDALE DR., SUITE B
MOUNTAIN VIEW, CA 94043 US
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Contact
SUSAN MARQUES
Other 510(k) Applications for this Contact
Regulation Number
882.5300
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Classification Product Code
GXP
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More FDA Info for this Product Code
Date Received
11/26/1999
Decision Date
08/31/2000
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
NE - Neurology
Review Advisory Committee
NE - Neurology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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