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FDA 510(k) Application Details - K170300
Device Classification Name
More FDA Info for this Device
510(K) Number
K170300
Device Name
Restrata Wound Matrix
Applicant
Acera Surgical, Inc.
10880 Baur Blvd.
St. Louis, MO 63132 US
Other 510(k) Applications for this Company
Contact
Tamas Kovacs
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
QSZ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
01/31/2017
Decision Date
04/26/2017
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
-
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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