SUREONE INSULIN SYRINGE


information about

Device Classification Name

syringe, piston

510(k) Number K002921
Device Name SUREONE INSULIN SYRINGE
Original Applicant
HOSUK CO., LTD.
52-6 dukjeong-ri, samsung-myun
umsung-gun, chungcheong, 

KR

Original Contact y. h kim
Regulation Number 880.5860
Classification Product Code
FMF  
Subsequent Product Code
FMI  
Date Received 09/19/2000
Decision Date 10/18/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General Hospital

510k Review Panel

General Hospital

Type Traditional
Reviewed by Third Party Yes

Combination Product

No

Recalls CDRH Recalls
Category: Uncategorized