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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 K942195
Device Name BX-400S
Applicant
Bloomex International, Inc.
295 Molnar Dr.
Elmwood Park,  NJ  07407
Applicant Contact BENJAMIN LAROUX
Correspondent
Bloomex International, Inc.
295 Molnar Dr.
Elmwood Park,  NJ  07407
Correspondent Contact BENJAMIN LAROUX
Regulation Number890.5850
Classification Product Code
IPF  
Date Received04/12/1994
Decision Date 08/14/1995
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
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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