FDA.report

510(k) K220759

Device
Armis VeriCyn Wound Wash
Applicant
Armis Biopharma, Inc.
510(k) number
K220759
Product code
FQH
Decision
Substantially Equivalent (SESE)
Decision date
2023-05-25
Date received
2022-03-15
Regulation
880.5475
Classification name
Lavage, Jet
Medical specialty
General Hospital
Review panel
General Hospital
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Related Records

Applicant Contact

Contact
Angela Mallery
Address
2950 E. Harmony Rd. Suite 252 Fort Collins CO US 80528 80528

FDA Registration Numbers

Source Documents

510(k) summary PDF

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