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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 K070117
Device Name SSAFE PLUS DISPOSABLE SAFETY SYRINGE, 3 CC AND 5 CC
Applicant
DOLOMITE BIOTECH SDN BHD
417 WHITNEY STREET
SAN LEANDRO,  CA  94577
Applicant Contact TIMOTHY LIEW
Correspondent
DOLOMITE BIOTECH SDN BHD
417 WHITNEY STREET
SAN LEANDRO,  CA  94577
Correspondent Contact TIMOTHY LIEW
Regulation Number880.5860
Classification Product Code
MEG  
Date Received01/12/2007
Decision Date 08/06/2007
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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