FDA 510(k) Application Details - K243843

Device Classification Name	More FDA Info for this Device
510(K) Number	K243843
Device Name	Tendon Protect (50242)
Applicant	Kerecis Limited Sundstraeti 38, 400 Isafjordur P.O. Box 151 Isafjordur 400 IS Other 510(k) Applications for this Company
Contact	Skuli Magnusson Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OWY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/13/2024
Decision Date	06/04/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review