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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 K033174
Device Name BMLS03-3
Applicant
Biomedical Life Systems, Inc.
P.O. Box 1360
Vista,  CA  92085 -1360
Applicant Contact RICHARD SAXON
Correspondent
Biomedical Life Systems, Inc.
P.O. Box 1360
Vista,  CA  92085 -1360
Correspondent Contact RICHARD SAXON
Regulation Number890.5850
Classification Product Code
IPF  
Date Received10/01/2003
Decision Date 06/30/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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