PANCREATIC DRAINAGE TUBE


Device Classification Name

catheter, biliary, diagnostic

510(k) Number K021672
Device Name PANCREATIC DRAINAGE TUBE
Original Applicant
AOMORI OLYMPUS CO., LTD.
2 corporate center dr.
melville, 
NY 
11747 -3157

Original Contact laura storms-tyler
Regulation Number 876.5010
Classification Product Code
FGE  
Date Received 05/21/2002
Decision Date 04/16/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Gastroenterology/Urology

510k Review Panel

Gastroenterology/Urology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No