MEDCOMP SC4


Device Classification Name

catheter, hemodialysis, implanted

510(k) Number K022678
Device Name MEDCOMP SC4
Original Applicant
MEDCOMP
1499 delp dr.
harleysville, 
PA 
19438

Original Contact florence a caikoski
Regulation Number 876.5540
Classification Product Code
MSD  
Subsequent Product Code
NFK  
Date Received 08/12/2002
Decision Date 02/24/2003
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