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FDA 510(k) Application Details - K071628
Device Classification Name
External Mandibular Fixator And/Or Distractor
More FDA Info for this Device
510(K) Number
K071628
Device Name
External Mandibular Fixator And/Or Distractor
Applicant
STRYKER CMF
750 TRADE CENTRE WAY
SUITE 200
KALAMAZOO, MI 49001 US
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Contact
TENNILLE FOLK
Other 510(k) Applications for this Contact
Regulation Number
872.4760
More FDA Info for this Regulation Number
Classification Product Code
MQN
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More FDA Info for this Product Code
Date Received
06/14/2007
Decision Date
08/10/2007
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
DE - Dental
Review Advisory Committee
DE - Dental
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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