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FDA 510(k) Application Details - K970561
Device Classification Name
Mesh, Surgical, Polymeric
More FDA Info for this Device
510(K) Number
K970561
Device Name
Mesh, Surgical, Polymeric
Applicant
ORGANOGENESIS, INC.
150 DAN RD.
CANTON, MA 02021 US
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Contact
DIANE E MINEAR, RAC
Other 510(k) Applications for this Contact
Regulation Number
878.3300
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Classification Product Code
FTL
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More FDA Info for this Product Code
Date Received
02/13/1997
Decision Date
08/01/1997
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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