CRE BALLOON DILATATION CATHETER


Device Classification Name

dilator, esophageal

510(k) Number K110833
Device Name CRE BALLOON DILATATION CATHETER
Applicant
Boston Scientific Corporation
100 boston scientific way
marlborough, 
MA 
01752

Applicant Contact janis taranto
Correspondent
Boston Scientific Corporation
100 boston scientific way
marlborough, 
MA 
01752

Correspodent Contact janis taranto
Regulation Number 876.5365
Classification Product Code
KNQ  
Subsequent Product Code
KOG  
Date Received 03/25/2011
Decision Date 04/20/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Gastroenterology/Urology

510k Review Panel

Gastroenterology/Urology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No