U.I. OCTOSON— 510(k) K801675
Substantially EquivalentAusonics Pty , Ltd.
FDA 510(k) clearance K801675 for U.I. OCTOSON, Substantially Equivalent on 1980-10-23. Applicant: Ausonics Pty , Ltd.. Device class: 2.
Clearance details
- Applicant
- Ausonics Pty , Ltd.
- Product code
- Code LEJ
- Device class
- Class 2
- Regulation
- 21 CFR 878.4635
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
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