SYNTHES SCOUT VESSEL GUARD


Device Classification Name

vessel guard or cover

510(k) Number K103558
Device Name SYNTHES SCOUT VESSEL GUARD
Applicant
SYNTHES SPINE
1302 wrights lane east
west chester, 
PA 
19380

Applicant Contact heather guerin
Correspondent
SYNTHES SPINE
1302 wrights lane east
west chester, 
PA 
19380

Correspodent Contact heather guerin
Regulation Number 870.3470
Classification Product Code
OMR  
Date Received 12/02/2010
Decision Date 02/18/2011
Decision

se – with limitations

(SESU)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No