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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 K101270
Device Name SWABFLSUH (3ML, 5ML, 10ML) MODEL 10331, 10351, 10311
Applicant
Excelsior Medical Corp.
4 Innovation Dr.
Dundas, On,  CA L2H 7P3
Applicant Contact NANCY RUTH
Correspondent
Excelsior Medical Corp.
4 Innovation Dr.
Dundas, On,  CA L2H 7P3
Correspondent Contact NANCY RUTH
Regulation Number880.5200
Classification Product Code
NGT  
Date Received05/06/2010
Decision Date 02/10/2011
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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