FDA 510(k) Application Details - K232780

Device Classification Name	Washer, Bolt Nut   More FDA Info for this Device
510(K) Number	K232780
Device Name	Washer, Bolt Nut
Applicant	CC-Instruments Inc 850 New Burton Road Suite 201 Dover, DE 19904 US Other 510(k) Applications for this Company
Contact	Juha Ranne 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	09/11/2023
Decision Date	12/18/2023
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