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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 DRIVE
DUNDAS, ON,  CA L2H 7P3
Applicant Contact NANCY RUTH
Correspondent
EXCELSIOR MEDICAL CORP.
4 INNOVATION DRIVE
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
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