UNIQSAFE ROTATABLE, RETRACTABLE SAFETY SYRINGES


Device Classification Name

syringe, antistick

510(k) Number K050116
Device Name UNIQSAFE ROTATABLE, RETRACTABLE SAFETY SYRINGES
Applicant
UNIQSAFE BIOMEDITECH CO., LTD.
3892 south america west trail
flagstaff, 
AZ 
86001

Applicant Contact jennifer reich
Correspondent
UNIQSAFE BIOMEDITECH CO., LTD.
3892 south america west trail
flagstaff, 
AZ 
86001

Correspodent Contact jennifer reich
Regulation Number 880.5860
Classification Product Code
MEG  
Date Received 01/18/2005
Decision Date 05/09/2005
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General Hospital

510k Review Panel

General Hospital

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No