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U.S. Department of Health and Human Services

510(k) Premarket Notification
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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
Correspondent Contact CHARLIE MACK
Regulation Number880.5860
Classification Product Code
MEG  
Date Received06/04/2012
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
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