FDA 510(k) Application Details - DEN000006

Device Classification Name Device, Engorgement, Clitoral

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510(K) Number DEN000006
Device Name Device, Engorgement, Clitoral
Applicant UROMETRICS, INC.
445 ETNA ST., SUITE 56
ST. PAUL, MN 55106 US
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Contact PHILIP A MESSINA
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Regulation Number 884.5970

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Classification Product Code NBV
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Date Received 04/27/2000
Decision Date 04/28/2000
Decision DENG -
Classification Advisory Committee OB - Obstetrics/Gynecology
Review Advisory Committee OB - Obstetrics/Gynecology
Statement / Summary / Purged Status
Type Post-NSE
Reviewed By Third Party N
Expedited Review



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