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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Saline, Vascular Access Flush
510(k) Number K060339
Device Name KENDALL MONOJECT PRE-FILL ADVANCED 0.9%SODIUM CHLORIDE FLUSH SYRINGES FOR STERILE DELIVERY
Applicant
TYCO HEALTHCARE/KENDALL
15 HAMPSHIRE STREET
MANSFIELD,  MA  02048
Applicant Contact BRIDGET GARDNER
Correspondent
TYCO HEALTHCARE/KENDALL
15 HAMPSHIRE STREET
MANSFIELD,  MA  02048
Correspondent Contact BRIDGET GARDNER
Regulation Number880.5200
Classification Product Code
NGT  
Date Received02/10/2006
Decision Date 04/28/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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