SAF-T CLOSED BLOOD COLLECTION SYSTEM WITH SAF-HOLDER DEVICE, WITH 21G, 23G, 25G SAF-T WING


Device Classification Name

tubes, vials, systems, serum separators, blood collection

510(k) Number K081229
Device Name SAF-T CLOSED BLOOD COLLECTION SYSTEM WITH SAF-HOLDER DEVICE, WITH 21G, 23G, 25G SAF-T WING
Applicant
SMITHS MEDICAL ASD, INC.
10 bowman dr.
keene, 
NH 
03431

Applicant Contact brian farias
Correspondent
SMITHS MEDICAL ASD, INC.
10 bowman dr.
keene, 
NH 
03431

Correspodent Contact brian farias
Regulation Number 862.1675
Classification Product Code
JKA  
Date Received 04/30/2008
Decision Date 07/21/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Clinical Chemistry

510k Review Panel

General Hospital

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No