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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 K011283
Device Name MONOJECT PREFILL 0.9% SODIUM CHLORIDE FLUSH SYRINGE
Applicant
THE KENDALL COMPANY
15 HAMPSHIRE ST.
MANSFIELD,  MA  02048
Applicant Contact DAVID A OLSON
Correspondent
THE KENDALL COMPANY
15 HAMPSHIRE ST.
MANSFIELD,  MA  02048
Correspondent Contact DAVID A OLSON
Regulation Number880.5200
Classification Product Code
NGT  
Date Received04/27/2001
Decision Date 10/15/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
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