FDA 510(k) Application Details - K030332

Device Classification Name Stimulator, Electrical, Transcutaneous, For Arthritis

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510(K) Number K030332
Device Name Stimulator, Electrical, Transcutaneous, For Arthritis
Applicant BIONICARE MEDICAL TECHNOLOGIES, INC.
47 R LOVETON CIRCLE
SPARKS, MD 21152 US
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Contact KENT HOFFMAN
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Regulation Number 882.5890

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Classification Product Code NYN
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Date Received 01/31/2003
Decision Date 06/06/2003
Decision SESE - SUBST EQUIV
Classification Advisory Committee NE - Neurology
Review Advisory Committee NE - Neurology
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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