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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 K012885
Device Name NEUROMOVE NM900
Applicant
Dan Med, Inc.
4 W. Dry Creek Circle,
Suite 260
Denver,  CO  80120
Applicant Contact THOMAS SANDGAARD
Correspondent
Dan Med, Inc.
4 W. Dry Creek Circle,
Suite 260
Denver,  CO  80120
Correspondent Contact THOMAS SANDGAARD
Regulation Number890.5850
Classification Product Code
IPF  
Subsequent Product Code
HCC  
Date Received08/28/2001
Decision Date 11/08/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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