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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 K932916
Device Name GALVANIC GENERATOR MODEL IMF4150/A
Applicant
Biomedical Life Systems, Inc.
1120 Sycamore Ave., Suite F
P.O. Box 1360
Vista,  CA  92083
Applicant Contact RICHARD SAXON
Correspondent
Biomedical Life Systems, Inc.
1120 Sycamore Ave., Suite F
P.O. Box 1360
Vista,  CA  92083
Correspondent Contact RICHARD SAXON
Regulation Number890.5850
Classification Product Code
IPF  
Date Received06/16/1993
Decision Date 01/07/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
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