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FDA 510(k) Application Details - K091763
Device Classification Name
Washer, Bolt Nut
More FDA Info for this Device
510(K) Number
K091763
Device Name
Washer, Bolt Nut
Applicant
INSTRATEK, INC.
210 SPRINGHILL DR.
SUITE 130
SPRING, TX 77386 US
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Contact
Jeff Seavey
Other 510(k) Applications for this Contact
Regulation Number
888.3030
More FDA Info for this Regulation Number
Classification Product Code
HTN
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
06/16/2009
Decision Date
08/14/2009
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OR - Orthopedic
Review Advisory Committee
OR - Orthopedic
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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