PS X SERIES (BASIC COMPONENTS AND CATHETER), PD X SERIES (CATHETER WITH ALL COMPONENTS)


Device Classification Name

catheter, peritoneal, long-term indwelling

510(k) Number K121383
Device Name PS X SERIES (BASIC COMPONENTS AND CATHETER), PD X SERIES (CATHETER WITH ALL COMPONENTS)
Applicant
MEDICAL COMPONENTS INC
1499 delp drive
harleysville, 
PA 
19438

Applicant Contact jean callow
Correspondent
MEDICAL COMPONENTS INC
1499 delp drive
harleysville, 
PA 
19438

Correspodent Contact jean callow
Regulation Number 876.5630
Classification Product Code
FJS  
Date Received 05/08/2012
Decision Date 09/05/2012
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