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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 WEST DRY CREEK CIRCLE,
SUITE 260
denver,  CO  80120
Applicant Contact thomas sandgaard
Correspondent
DAN MED, INC.
4 WEST 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
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