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FDA 510(k) Application Details - K121304
Device Classification Name
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510(K) Number
K121304
Device Name
OSTEOMED CRANIAL DISTRACTION SYSTEM
Applicant
OSTEOMED
3885 Arapaho Rd
ADDISON, TX 75001 US
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Contact
PIEDAD PENA
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Regulation Number
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Classification Product Code
PBJ
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Date Received
05/01/2012
Decision Date
08/22/2012
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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