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FDA 510(k) Application Details - K201572
Device Classification Name
More FDA Info for this Device
510(K) Number
K201572
Device Name
TAPESTRY Biointegrative Implant
Applicant
Embody, Inc.
4211 Monarch Way, Ste 500
Norfolk, VA 23508 US
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Contact
Scott Bruder
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Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
OWY
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More FDA Info for this Product Code
Date Received
06/11/2020
Decision Date
10/19/2020
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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