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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Muscle, Powered
510(k) Number K972055
Device Name MSI MAGNA-STYM
Applicant
Microvas Systems, Inc.
400 N. Loop 1604, Suite 340
San Antonio,  TX  78232
Applicant Contact LARRY COHEN
Correspondent
Microvas Systems, Inc.
400 N. Loop 1604, Suite 340
San Antonio,  TX  78232
Correspondent Contact LARRY COHEN
Regulation Number890.5850
Classification Product Code
IPF  
Date Received06/02/1997
Decision Date 08/29/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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