CorMatrix Cor Patch (3 cm x 5 cm)(single pack), CorMatrix Cor Patch (4 cm x 7 cm)(single pack), CorMatrix Cor Patch (7 cm x 10 cm)(single pack)— 510(k) K181038

Name: FDA 510(k) clearance K181038
Creator: U.S. Food and Drug Administration
Published: 2018-10-10

Substantially Equivalent

Cormatrix Cardiovascular, Inc.

FDA 510(k) clearance K181038 for CorMatrix Cor Patch (3 cm x 5 cm)(single pack), CorMatrix Cor Patch (4 cm x 7 cm)(single pack), CorMatrix Cor Patch (7 cm x 10 cm)(single pack), Substantially Equivalent on 2018-10-10. Applicant: Cormatrix Cardiovascular, Inc.. Device class: 2.

Clearance details

Applicant: Cormatrix Cardiovascular, Inc.
Product code: Code PSQ
Device class: Class 2
Regulation: 21 CFR 870.3470
Advisory panel: Cardiovascular
Date received: 2018-04-19
Decision date: 2018-10-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Roswell, GA, US

Download summary PDF View on FDA.gov ↗

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