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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Needle, Hypodermic, Single Lumen
510(k) Number K012283
Device Name SOLOGARD LOCKING PLUS SYRINGE WITH NEEDLE
Applicant
SAFEGARD MEDICAL PRODUCTS, INC.
52 DRAGON CT.
WOBURN,  MA  01801
Applicant Contact PATRICK GRANT, JR.
Correspondent
SAFEGARD MEDICAL PRODUCTS, INC.
52 DRAGON CT.
WOBURN,  MA  01801
Correspondent Contact PATRICK GRANT, JR.
Regulation Number880.5570
Classification Product Code
FMI  
Date Received07/20/2001
Decision Date 10/01/2001
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
Predetermined Change
Control Plan Authorized		 No
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