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FDA 510(k) Application Details - K190516
Device Classification Name
Washer, Bolt Nut
More FDA Info for this Device
510(K) Number
K190516
Device Name
Washer, Bolt Nut
Applicant
CONMED Corporation
525 French Road
Utica, NY 13502 US
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Contact
Diana L. Nader-Martone
Other 510(k) Applications for this Contact
Regulation Number
888.3030
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Classification Product Code
HTN
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More FDA Info for this Product Code
Date Received
03/04/2019
Decision Date
06/28/2019
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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