FDA 510(k) Application Details - K980410

Device Classification Name Electrode, Cutaneous

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510(K) Number K980410
Device Name Electrode, Cutaneous
Applicant SPECIALIZED LABORATORY EQUIPMENT, LTD.
3407 BAY AVE.
CHICO, CA 95973 US
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Contact FRANK FERGUSON
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Regulation Number 882.1320

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Classification Product Code GXY
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Date Received 02/03/1998
Decision Date 10/22/1998
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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