JOSTENT SELFX, MODELS 015SX4406; 015SX4408; 015SX4410; 015SX680; 015SX6808; 015SX6810


Device Classification Name

catheter, biliary, diagnostic

510(k) Number K030053
Device Name JOSTENT SELFX, MODELS 015SX4406; 015SX4408; 015SX4410; 015SX680; 015SX6808; 015SX6810
Original Applicant
JOMED AG
15330 avenue of science
san diego, 
CA 
92128

Original Contact terry schultz
Regulation Number 876.5010
Classification Product Code
FGE  
Date Received 12/23/2002
Decision Date 03/31/2003
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