THROUGH-THE-PEG (TTP) JEJUNOSTOMY TUBE KIT


Device Classification Name

tubes, gastrointestinal (and accessories)

510(k) Number K072476
Device Name THROUGH-THE-PEG (TTP) JEJUNOSTOMY TUBE KIT
Applicant
Boston Scientific Corporation
100 boston scientific way
marlborough, 
MA 
01752

Applicant Contact virginia carr
Correspondent
Boston Scientific Corporation
100 boston scientific way
marlborough, 
MA 
01752

Correspodent Contact virginia carr
Regulation Number 876.5980
Classification Product Code
KNT  
Date Received 09/04/2007
Decision Date 12/14/2007
Decision

substantially equivalent – kit

(SESK)

Regulation Medical Specialty

Gastroenterology/Urology

510k Review Panel

Gastroenterology/Urology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No