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FDA 510(k) Application Details - K072951
Device Classification Name
More FDA Info for this Device
510(K) Number
K072951
Device Name
PARIETENE DUO AND QUADRA POLYPROPYLENE MESHES
Applicant
SOFRADIM PRODUCTION
150 GLOVER AVENUE
NORWALK, CT 06856 US
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Contact
SHARON ALEXANDER
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Regulation Number
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Classification Product Code
OTP
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More FDA Info for this Product Code
Date Received
10/18/2007
Decision Date
12/19/2007
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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