1ML UNITRACT INSULIN SYRINGE 27G*1/2 , 1ML UNITRACT SYRINGE 29G*1/2


Device Classification Name

syringe, antistick

510(k) Number K080877
Device Name 1ML UNITRACT INSULIN SYRINGE 27G*1/2 , 1ML UNITRACT SYRINGE 29G*1/2
Applicant
UNILIFE MEDICAL SOLUTIONS LIMITED
level 5, 35 clarence street
sydney, nsw, 

AU

2000

Applicant Contact michelle gow
Correspondent
UNILIFE MEDICAL SOLUTIONS LIMITED
level 5, 35 clarence street
sydney, nsw, 

AU

2000

Correspodent Contact michelle gow
Regulation Number 880.5860
Classification Product Code
MEG  
Date Received 03/31/2008
Decision Date 10/21/2008
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