ICC INSULIN SAFEPRO SAFETY SYRINGE


Device Classification Name

syringe, antistick

510(k) Number K050134
Device Name ICC INSULIN SAFEPRO SAFETY SYRINGE
Applicant
FORMOSA MEDICAL DEVICES, INC.
16f,no.182,sect.2
tunhua s. road
taipei, 

TW

106

Applicant Contact c. y. lin
Correspondent
FORMOSA MEDICAL DEVICES, INC.
16f,no.182,sect.2
tunhua s. road
taipei, 

TW

106

Correspodent Contact c. y. lin
Regulation Number 880.5860
Classification Product Code
MEG  
Date Received 01/21/2005
Decision Date 04/05/2005
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General Hospital

510k Review Panel

General Hospital

summary

summary

Type Abbreviated
Reviewed by Third Party No

Combination Product

No