COLLAGEN TENDON SHEET-D


Device Classification Name

mesh, surgical

510(k) Number K122048
Device Name COLLAGEN TENDON SHEET-D
Applicant
ROTATION MEDICAL, INC.
15350 25th avenue n
suite 100
plymouth, 
MN 
55447

Applicant Contact jeff sims
Correspondent
ROTATION MEDICAL, INC.
15350 25th avenue n
suite 100
plymouth, 
MN 
55447

Correspodent Contact jeff sims
Regulation Number 878.3300
Classification Product Code
FTM  
Subsequent Product Code
OWY  
Date Received 07/12/2012
Decision Date 01/08/2013
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General & Plastic Surgery

510k Review Panel

General & Plastic Surgery

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No