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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 K010749
Device Name ELECTRO NEUROMUSCULAR STIMULATOR, MODEL NMS-DIGITAL
Applicant
BIOMEDICAL LIFE SYSTEMS, INC.
P.O. BOX 1360
VISTA,  CA  92085 -1360
Applicant Contact RICHARD SAXON
Correspondent
BIOMEDICAL LIFE SYSTEMS, INC.
P.O. BOX 1360
VISTA,  CA  92085 -1360
Correspondent Contact RICHARD SAXON
Regulation Number890.5850
Classification Product Code
IPF  
Date Received03/13/2001
Decision Date 09/28/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
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