FDA 510(k) Application Details - K991199

Device Classification Name Electrode, Cutaneous

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510(K) Number K991199
Device Name Electrode, Cutaneous
Applicant BIOMED PRODUCTS
5262 VISTA GRANDE DR.
SANTA ROSA, CA 95403 US
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Contact TIMOTHY THYGESON
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Regulation Number 882.1320

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Classification Product Code GXY
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Date Received 04/08/1999
Decision Date 06/22/1999
Decision SESE - SUBST EQUIV
Classification Advisory Committee NE - Neurology
Review Advisory Committee NE - Neurology
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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