SCIZER (SC1-M410)— 510(k) K230100
Substantially EquivalentClassys, Inc.
FDA 510(k) clearance K230100 for SCIZER (SC1-M410), Substantially Equivalent on 2023-11-03. Applicant: Classys, Inc.. Device class: 2.
Clearance details
- Applicant
- Classys, Inc.
- Product code
- Code OHV
- Device class
- Class 2
- Regulation
- 21 CFR 878.4590
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Seoul, KR
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