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FDA 510(k) Application Details - K220650
Device Classification Name
Washer, Bolt Nut
More FDA Info for this Device
510(K) Number
K220650
Device Name
Washer, Bolt Nut
Applicant
TriMed, Inc.
27533 Avenue Hopkins
Santa Clarita, CA 91355 US
Other 510(k) Applications for this Company
Contact
David Medoff
Other 510(k) Applications for this Contact
Regulation Number
888.3030
More FDA Info for this Regulation Number
Classification Product Code
HTN
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More FDA Info for this Product Code
Date Received
03/07/2022
Decision Date
06/01/2022
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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