FDA 510(k) Application Details - K983897

Device Classification Name Set, Anesthesia, Paracervical

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510(K) Number K983897
Device Name Set, Anesthesia, Paracervical
Applicant RI MOS. S.R.L.
100 MAIN ST.
SUITE 120
CONCORD, MA 01742 US
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Contact ADENA S RIEMER
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Regulation Number 884.5100

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Classification Product Code HEE
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Date Received 11/03/1998
Decision Date 02/01/1999
Decision SESE - SUBST EQUIV
Classification Advisory Committee OB - Obstetrics/Gynecology
Review Advisory Committee OB - Obstetrics/Gynecology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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