BIOTEQ I.V. (INTRAVENOUS) SET


the company

Device Classification Name

set, administration, intravascular

510(k) Number K002449
Device Name BIOTEQ I.V. (INTRAVENOUS) SET
Original Applicant
BIOTEQUE CORP.
900 n. switzer canyon dr. #142
flagstaff, 
AZ 
86001

Original Contact jennifer chen
Regulation Number 880.5440
Classification Product Code
FPA  
Date Received 08/09/2000
Decision Date 12/22/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General Hospital

510k Review Panel

General Hospital

Type Traditional
Reviewed by Third Party No

Combination Product

No