RETRO REPAIR KIT, MODEL PRRK5


Device Classification Name

kit, repair, catheter, hemodialysis

510(k) Number K022644
Device Name RETRO REPAIR KIT, MODEL PRRK5
Original Applicant
SPIRE BIOMEDICAL, INC.
one patriots park
bedford, 
MA 
01730 -2396

Original Contact donald fickett
Regulation Number 876.5540
Classification Product Code
NFK  
Date Received 08/08/2002
Decision Date 11/06/2002
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