Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
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
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact