Protect X Level 3 Isolation Gown— 510(k) K211538
Substantially EquivalentAzac Group
FDA 510(k) clearance K211538 for Protect X Level 3 Isolation Gown, Substantially Equivalent on 2021-11-17. Applicant: Azac Group. Device class: 2.
Clearance details
- Applicant
- Azac Group
- Product code
- Code FYC
- Device class
- Class 2
- Regulation
- 21 CFR 878.4040
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- City Of Industry, CA, US
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