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FDA 510(k) Application Details - K083722
Device Classification Name
More FDA Info for this Device
510(K) Number
K083722
Device Name
ASCEND
Applicant
CALDERA MEDICAL, INC.
28632 ROADSIDE DR., SUITE 260
AGOURA HILLS, CA 91301 US
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Contact
MARA KORSUNSKY
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Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
OTP
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/15/2008
Decision Date
03/31/2009
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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