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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Electrical, Transcutaneous, For Arthritis
510(k) Number K052625
Device Name BIONICARE STIMULATOR SYSTEM, MODEL BIO-1000
Applicant
BIONICARE MEDICAL TECHNOLOGIES, INC.
47 R LOVETON CIRCLE
SPARKS,  MD  21152
Applicant Contact KENT HOFFMAN
Correspondent
BIONICARE MEDICAL TECHNOLOGIES, INC.
47 R LOVETON CIRCLE
SPARKS,  MD  21152
Correspondent Contact KENT HOFFMAN
Regulation Number882.5890
Classification Product Code
NYN  
Date Received09/23/2005
Decision Date 12/05/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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