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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 K946298
Device Name BIOSTIM-HV
Applicant
Progressive Concepts, Inc.
22194 Hillsboro Rd.
Denton,  MD  21629
Applicant Contact W R FISCHER
Correspondent
Progressive Concepts, Inc.
22194 Hillsboro Rd.
Denton,  MD  21629
Correspondent Contact W R FISCHER
Regulation Number890.5850
Classification Product Code
IPF  
Date Received12/27/1994
Decision Date 05/11/1995
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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