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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 K012736
Device Name MONOJECT SAFETY NEEDLE
Applicant
TYCO HEALTHCARE
15 HAMPSHIRE ST.
MANSFIELD,  MA  02048
Applicant Contact DAVID A OLSON
Correspondent
TYCO HEALTHCARE
15 HAMPSHIRE ST.
MANSFIELD,  MA  02048
Correspondent Contact DAVID A OLSON
Regulation Number880.5570
Classification Product Code
FMI  
Date Received08/16/2001
Decision Date 10/25/2001
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
Recalls CDRH Recalls
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