COOK AND COOK SPECTRUM CENTRAL VENOUS CATHETERS


Device Classification Name

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

510(k) Number K081113
Device Name COOK AND COOK SPECTRUM CENTRAL VENOUS CATHETERS
Applicant
COOK, INC.
750 daniels way
bloomington, 
IN 
47404

Applicant Contact susanne galin
Correspondent
COOK, INC.
750 daniels way
bloomington, 
IN 
47404

Correspodent Contact susanne galin
Regulation Number 880.5200
Classification Product Code
FOZ  
Date Received 04/18/2008
Decision Date 07/30/2008
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

Recalls CDRH Recalls