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FDA 510(k) Application Details - K132510
Device Classification Name
Washer, Bolt Nut
More FDA Info for this Device
510(K) Number
K132510
Device Name
Washer, Bolt Nut
Applicant
BIOPRO, INC.
3150 E. 200TH ST
PRIOR LAKE, MN 55372 US
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Contact
AL LIPPINCOTT
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
08/12/2013
Decision Date
10/24/2013
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OR - Orthopedic
Review Advisory Committee
OR - Orthopedic
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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