FDA 510(k) Application Details - K050740

Device Classification Name Stimulator, Nerve, Transcutaneous, For Pain Relief

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510(K) Number K050740
Device Name Stimulator, Nerve, Transcutaneous, For Pain Relief
Applicant MICROWARE INC
2314 SE PARK CREST AVE
WANCOUVER, WA 98683 US
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Contact MICHAEL B MCGRAW
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Regulation Number 882.5890

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Classification Product Code GZJ
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Date Received 03/22/2005
Decision Date 04/06/2005
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 Y
Expedited Review



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