AUTO-DISABLE STERILE SAFTY SYRING FOR SINGLE USE


Device Classification Name

syringe, antistick

510(k) Number K121637
Device Name AUTO-DISABLE STERILE SAFTY SYRING FOR SINGLE USE
Applicant
SUNWELL BIOTECH CO., LTD
77325 joyce way
echo, 
OR 
97826

Applicant Contact charlie mack
Correspondent
SUNWELL BIOTECH CO., LTD
77325 joyce way
echo, 
OR 
97826

Correspodent Contact charlie mack
Regulation Number 880.5860
Classification Product Code
MEG  
Date Received 06/04/2012
Decision Date 10/25/2012
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