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FDA 510(k) Application Details - K983181
Device Classification Name
System, Abortion, Vacuum
More FDA Info for this Device
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
Other 510(k) Applications for this Contact
Regulation Number
884.5070
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Classification Product Code
HHI
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More FDA Info for this Product Code
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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