FDA 510(k) Application Details - K983181

Device Classification Name System, Abortion, Vacuum

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510(K) Number K983181
Device Name System, Abortion, Vacuum
Applicant CYTOPREP INC. EST.
RENKWILER 593
ESCHEN 9492 LI
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Contact K G PAGANIS
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Regulation Number 884.5070

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Classification Product Code HHI
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Date Received 09/11/1998
Decision Date 11/16/1998
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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