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FDA 510(k) Application Details - K011069
Device Classification Name
Insufflator, Hysteroscopic
More FDA Info for this Device
510(K) Number
K011069
Device Name
Insufflator, Hysteroscopic
Applicant
DAVOL, INC., SUB. C.R. BARD, INC.
100 SOCKANOSSETT CROSSROAD
CRANSTON, RI 02920 US
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Contact
LUCINDA L FOX
Other 510(k) Applications for this Contact
Regulation Number
884.1700
More FDA Info for this Regulation Number
Classification Product Code
HIG
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
04/09/2001
Decision Date
08/16/2001
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
Y
Expedited Review
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