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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
Recalls CDRH Recalls
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