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FDA 510(k) Application Details - K090733
Device Classification Name
Tong, Skull For Traction
More FDA Info for this Device
510(K) Number
K090733
Device Name
Tong, Skull For Traction
Applicant
PMT CORP.
1500 PARK RD.
P.O. OX 610
CHANHASSEN, MN 55317 US
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Contact
ERIC CAILLE
Other 510(k) Applications for this Contact
Regulation Number
882.5960
More FDA Info for this Regulation Number
Classification Product Code
HAX
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
03/19/2009
Decision Date
07/28/2009
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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