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FDA 510(k) Application Details - K190143
Device Classification Name
Washer, Bolt Nut
More FDA Info for this Device
510(K) Number
K190143
Device Name
Washer, Bolt Nut
Applicant
Corin USA
12750 Citrus Park Lane, Suite 120
Tampa, FL 33625 US
Other 510(k) Applications for this Company
Contact
Lucinda Gerber
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
01/29/2019
Decision Date
11/04/2019
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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