510(k) K230966

Device
angiOCCLUDE Ligating Clips
Applicant
A2 Medical Systems, LLC
510(k) number
K230966
Product code
FZP
Decision
Substantially Equivalent (SESE)
Decision date
2023-09-19
Date received
2023-04-05
Regulation
878.4300
Classification name
Clip, Implantable
Medical specialty
General, Plastic Surgery
Review panel
General, Plastic Surgery
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
Robert Hall
Address
6387 Technology Ave. Kalamazoo MI US 49009 49009

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON

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