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FDA 510(k) Application Details - K991625
Device Classification Name
Motor, Drill, Pneumatic
More FDA Info for this Device
510(K) Number
K991625
Device Name
Motor, Drill, Pneumatic
Applicant
KOMET MEDICAL
2188 KNOLL DR.
SAVANNAH, GA 31419 US
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Contact
COURTNEY S PARADICE
Other 510(k) Applications for this Contact
Regulation Number
882.4370
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Classification Product Code
HBB
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More FDA Info for this Product Code
Date Received
05/11/1999
Decision Date
07/30/1999
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
NE - Neurology
Review Advisory Committee
NE - Neurology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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