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FDA 510(k) Application Details - K022445
Device Classification Name
Hysteroscope (And Accessories)
More FDA Info for this Device
510(K) Number
K022445
Device Name
Hysteroscope (And Accessories)
Applicant
OLYMPUS OPTICAL CO., LTD.
TWO CORPORATE CENTER DR.
MELVILLE, NY 11747-3157 US
Other 510(k) Applications for this Company
Contact
LAURA STORMS-TYLER
Other 510(k) Applications for this Contact
Regulation Number
884.1690
More FDA Info for this Regulation Number
Classification Product Code
HIH
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
07/25/2002
Decision Date
01/24/2003
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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