510(k) K233571
- Device
- GCI Surgical Gown
- Applicant
- George Courey, Inc.
- 510(k) number
- K233571
- Product code
- FYA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2024-08-02
- Date received
- 2023-11-06
- Regulation
- 878.4040
- Classification name
- Gown, Surgical
- 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
- Cort Naab
- Address
- 6620, Ernest-Cormier Laval CA H7C 2T5 H7C 2T5
FDA Registration Numbers
- 3036773433
- 3030088999
- 3002807090
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Source Documents
FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON
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