ENDOVIVE INITIAL PLACEMENT DIRECT PEJ KIT, MODELS 6520 & 6521


Device Classification Name

tubes, gastrointestinal (and accessories)

510(k) Number K022648
Device Name ENDOVIVE INITIAL PLACEMENT DIRECT PEJ KIT, MODELS 6520 & 6521
Original Applicant
BOSTON SCIENTIFIC CORP.
one boston scientific place
natick, 
MA 
01760 -1537

Original Contact paige sweeney
Regulation Number 876.5980
Classification Product Code
KNT  
Date Received 08/09/2002
Decision Date 09/05/2002
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