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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 K003555
Device Name SOLO-SAFE SAFETY SYRINGE, SIZE-3CC
Applicant
Spectrum Biotech, Inc.
821 E. 17th St.
N.Vancouver, British Columbia,  CA V7L 2X2
Applicant Contact IAN MCDOUGALL
Correspondent
Spectrum Biotech, Inc.
821 E. 17th St.
N.Vancouver, British Columbia,  CA V7L 2X2
Correspondent Contact IAN MCDOUGALL
Regulation Number880.5860
Classification Product Code
MEG  
Date Received11/17/2000
Decision Date 08/29/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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