GAMMEX PI Hybrid Micro (8 models)— 510(k) K231902
Substantially EquivalentAnsell Healthcare
FDA 510(k) clearance K231902 for GAMMEX PI Hybrid Micro (8 models), Substantially Equivalent on 2023-10-20. Applicant: Ansell Healthcare. Device class: 1.
Clearance details
- Device name as filed
- GAMMEX PI Hybrid Micro (340002055); GAMMEX PI Hybrid Micro (340002060); GAMMEX PI Hybrid Micro (340002065); GAMMEX PI Hybrid Micro (340002070); GAMMEX PI Hybrid Micro (340002075); GAMMEX PI Hybrid Micro (340002080); GAMMEX PI Hybrid Micro (340002085); GAMMEX PI Hybrid Micro (340002090)
- Applicant
- Ansell Healthcare
- Product code
- Code KGO
- Device class
- Class 1
- Regulation
- 21 CFR 878.4460
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Reno, NV, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.