SUREONE INSULIN SYRINGE, 31 GAUGE X 5/16


Device Classification Name

syringe, piston

510(k) Number K021197
Device Name SUREONE INSULIN SYRINGE, 31 GAUGE X 5/16
Original Applicant
HOSUK CO., LTD.
5353 wayzata blvd., ste 505
minneapolis, 
MN 
55416

Original Contact carole stamp
Regulation Number 880.5860
Classification Product Code
FMF  
Subsequent Product Code
FMI  
Date Received 04/16/2002
Decision Date 04/26/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General Hospital

510k Review Panel

General Hospital

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls