ACCUTRAC


Device Classification Name

powered laser surgical instrument

510(k) Number K110686
Device Name ACCUTRAC
Applicant
BOSTON SCIENTIFIC CORP.
100 boston scientific way
m21
marlborough, 
MA 
01752

Applicant Contact lauren anderson
Correspondent
BOSTON SCIENTIFIC CORP.
100 boston scientific way
m21
marlborough, 
MA 
01752

Correspodent Contact lauren anderson
Regulation Number 878.4810
Classification Product Code
GEX  
Date Received 03/11/2011
Decision Date 03/28/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General & Plastic Surgery

510k Review Panel

General & Plastic Surgery

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No