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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Flowmeter, Blood, Cardiovascular
510(k) Number K110438
Device Name SENSILASE PAD-IQ
Applicant
Vasamed, Inc.
800 Levanger Lane
Stoughton,  WI  53589
Applicant Contact Gary J Syring
Correspondent
Vasamed, Inc.
800 Levanger Lane
Stoughton,  WI  53589
Correspondent Contact Gary J Syring
Regulation Number870.2100
Classification Product Code
DPW  
Date Received02/15/2011
Decision Date 05/04/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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