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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 K932739
Device Name FAST START NEUROMUSCULAR STIMULATOR
Applicant
Madeoutback Co. , Ltd.
6202 S. 121st Ave.
Tolleson,  AZ  85353
Applicant Contact SCOTT O OPENSHAW
Correspondent
Madeoutback Co. , Ltd.
6202 S. 121st Ave.
Tolleson,  AZ  85353
Correspondent Contact SCOTT O OPENSHAW
Regulation Number890.5850
Classification Product Code
IPF  
Date Received06/07/1993
Decision Date 01/07/1994
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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