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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 K972213
Device Name MS-700
Applicant
Alan S. Lee
2121 W Beacon Ave.
Anaheim,  CA  92804
Applicant Contact ALAN S LEE
Correspondent
Alan S. Lee
2121 W Beacon Ave.
Anaheim,  CA  92804
Correspondent Contact ALAN S LEE
Regulation Number870.2100
Classification Product Code
DPW  
Date Received06/12/1997
Decision Date 03/13/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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