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FDA 510(k) Application Details - K972426
Device Classification Name
Hysteroscope (And Accessories)
More FDA Info for this Device
510(K) Number
K972426
Device Name
Hysteroscope (And Accessories)
Applicant
IMAGYN MEDICAL, INC.
27651 LA PAZ RD.
LAGUNA NIGUEL, CA 92656-3917 US
Other 510(k) Applications for this Company
Contact
DEBRA A RINDERER
Other 510(k) Applications for this Contact
Regulation Number
884.1690
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Classification Product Code
HIH
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
06/27/1997
Decision Date
09/23/1997
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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