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FDA 510(k) Application Details - K980096
Device Classification Name
Curette, Uterine
More FDA Info for this Device
510(K) Number
K980096
Device Name
Curette, Uterine
Applicant
IMAGYN MEDICAL TECHNOLOGIES, INC.
27651 LA PAZ RD.
LAGUNA NIGUEL, CA 92677-3917 US
Other 510(k) Applications for this Company
Contact
RONALD H BERGESON
Other 510(k) Applications for this Contact
Regulation Number
884.4530
More FDA Info for this Regulation Number
Classification Product Code
HCY
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
01/09/1998
Decision Date
05/01/1998
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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