FDA.reportPublic FDA data

510(k) K212579

Device
FortiShield (Biosynthetic Wound Matrix)
Applicant
Organogenesis, Inc.
510(k) number
K212579
Product code
KGN
Decision
Substantially Equivalent (SESE)
Decision date
2023-05-02
Date received
2021-08-16
Classification name
Wound Dressing With Animal-Derived Material(S)
Medical specialty
Unknown
Review panel
Unknown
Device class
U
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Christina Nichols
Address
150 Dan Rd. Canton MA US 02021 02021

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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