FDA 510(k) Application Details - K032239

Device Classification Name Media, Electroconductive

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510(K) Number K032239
Device Name Media, Electroconductive
Applicant PRIZM MEDICAL, INC.
111 LAUREL RIDGE DRIVE
ALPHARETTA, GA 30004 US
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Contact JULIE STEPHENS
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Regulation Number 882.1275

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Classification Product Code GYB
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Date Received 07/21/2003
Decision Date 07/30/2004
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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