SYNOVIS COLLAGEN MATRIX (TBD)


Device Classification Name

patch, pledget and intracardiac, petp, ptfe, polypropylene

510(k) Number K122306
Device Name SYNOVIS COLLAGEN MATRIX (TBD)
Applicant
SYNOVIS SURGICAL INNOVATIONS
2575 university ave.
west
st. paul, 
MN 
55114 -1024

Applicant Contact jodi jorgenson
Correspondent
SYNOVIS SURGICAL INNOVATIONS
2575 university ave.
west
st. paul, 
MN 
55114 -1024

Correspodent Contact jodi jorgenson
Regulation Number 870.3470
Classification Product Code
DXZ  
Date Received 08/01/2012
Decision Date 03/08/2013
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No

Category: Uncategorized