PHLEBOTOMY BAG WITH VALVE & 17G X 1, MODEL CM-PH17X1B, CM-PH17X1C


Device Classification Name

set, i.v. fluid transfer

510(k) Number K080174
Device Name PHLEBOTOMY BAG WITH VALVE & 17G X 1, MODEL CM-PH17X1B, CM-PH17X1C
Applicant
CARDIOMED SUPPLIES, INC.
199 st. david street
lindsay-ontario, 

CA

k9v 5k7

Applicant Contact christian g dube
Correspondent
CARDIOMED SUPPLIES, INC.
199 st. david street
lindsay-ontario, 

CA

k9v 5k7

Correspodent Contact christian g dube
Regulation Number 880.5440
Classification Product Code
LHI  
Date Received 01/24/2008
Decision Date 04/23/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General Hospital

510k Review Panel

General Hospital

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No