FDA 510(k) Application Details - K140300

Device Classification Name	More FDA Info for this Device
510(K) Number	K140300
Device Name	COLLAGEN TENDON SHEET-DDI (CTS-DDI)
Applicant	ROTATION MEDICAL, INC. 15350 25TH AVENUE N SUITE 100 PLYMOUTH, MN 55447 US Other 510(k) Applications for this Company
Contact	JEFF SIMS 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	02/06/2014
Decision Date	03/26/2014
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review