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FDA 510(k) Application Details - K100559
Device Classification Name
Hysteroscope (And Accessories)
More FDA Info for this Device
510(K) Number
K100559
Device Name
Hysteroscope (And Accessories)
Applicant
INTERLACE MEDICAL INC.
135 NEWBURY ST
FRAMINGHAM, MA 01701 US
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Contact
John Vozella
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
03/01/2010
Decision Date
03/30/2010
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OB - Obstetrics/Gynecology
Review Advisory Committee
OB - Obstetrics/Gynecology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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