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FDA 510(k) Application Details - K112386
Device Classification Name
More FDA Info for this Device
510(K) Number
K112386
Device Name
EXAIR ANTERIOR AND POSTERIOR PROLAPSE REPAIR SYSTEM
Applicant
COLOPLAST CORP.
1601 WEST RIVER N
MINNEAPOLIS, MN 55411 US
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Contact
TIM CRABTREE
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Regulation Number
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Classification Product Code
OTP
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Date Received
08/18/2011
Decision Date
09/08/2011
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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