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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 K862031
Device Name HAWKINS MINI-E.B.A.
Applicant
Pb Sales C/O Geller & Bozeman
Suite 1200 Two Century Plz.
2049 Century Park E.
Los Angeles,  CA  90067
Applicant Contact JAY H GELLER
Correspondent
Pb Sales C/O Geller & Bozeman
Suite 1200 Two Century Plz.
2049 Century Park E.
Los Angeles,  CA  90067
Correspondent Contact JAY H GELLER
Regulation Number890.5850
Classification Product Code
IPF  
Date Received05/28/1986
Decision Date 07/14/1986
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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