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FDA 510(k) Application Details - K052625
Device Classification Name
Stimulator, Electrical, Transcutaneous, For Arthritis
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510(K) Number
K052625
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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More FDA Info for this Product Code
Date Received
09/23/2005
Decision Date
12/05/2005
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
NE - Neurology
Review Advisory Committee
NE - Neurology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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