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FDA 510(k) Application Details - K203600
Device Classification Name
Mesh, Surgical
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510(K) Number
K203600
Device Name
Mesh, Surgical
Applicant
Alafair Biosciences Inc
6101 W Courtyard Drive ste 2-225
Austin, TX 78730 US
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Contact
Angela Mallery
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Regulation Number
878.3300
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Classification Product Code
FTM
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More FDA Info for this Product Code
Date Received
12/09/2020
Decision Date
03/09/2021
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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