FDA 510(k) Application Details - K023212

Device Classification Name Electrode, Cutaneous

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510(K) Number K023212
Device Name Electrode, Cutaneous
Applicant AG GARMENTS
1762 COLUMBIA ST.
SAN DIEGO, CA 92101 US
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Contact ATHENA SHUDDE
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Regulation Number 882.1320

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Classification Product Code GXY
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Date Received 09/26/2002
Decision Date 12/13/2002
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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