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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 K955736
Device Name STIM-8
Applicant
BMR LTD.
14900 SWEITZER LN.
SUITE 200
LAURAL,  MD  20707
Applicant Contact TOM BOONE
Correspondent
BMR LTD.
14900 SWEITZER LN.
SUITE 200
LAURAL,  MD  20707
Correspondent Contact TOM BOONE
Regulation Number890.5850
Classification Product Code
IPF  
Date Received12/18/1995
Decision Date 05/22/1996
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
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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