BIOSENSORS CENTRAL VENOUS CATHETER KITS


Device Classification Name

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

510(k) Number K002786
Device Name BIOSENSORS CENTRAL VENOUS CATHETER KITS
Original Applicant
SUNSCOPE INTL., INC.
20250 acacia st., suite 115
newport beach, 
CA 
92660

Original Contact jorge haider
Regulation Number 880.5200
Classification Product Code
FOZ  
Date Received 09/07/2000
Decision Date 11/17/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General Hospital

510k Review Panel

General Hospital

Type Traditional
Reviewed by Third Party No

Combination Product

No