SPECTRUM SILICONE CATHETER


Device Classification Name

catheter,intravascular,therapeutic,short-term less than 30 days

510(k) Number K021557
Device Name SPECTRUM SILICONE CATHETER
Original Applicant
COOK, INC.
925 south curry pike
p.o. box 489
bloomington, 
IN 
47402

Original Contact april lavender
Regulation Number 880.5200
Classification Product Code
FOZ  
Subsequent Product Code
LJS  
Date Received 05/13/2002
Decision Date 05/30/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General Hospital

510k Review Panel

General Hospital

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No