OMEGA EXTENDED MALAR AND OMEGA CONTOURED MALAR— 510(k) K871074
Substantially EquivalentOmega Silicone, Inc.
FDA 510(k) clearance K871074 for OMEGA EXTENDED MALAR AND OMEGA CONTOURED MALAR, Substantially Equivalent on 1987-04-10. Applicant: Omega Silicone, Inc.. Device class: 2.
Clearance details
- Applicant
- Omega Silicone, Inc.
- Product code
- Code FWP
- Device class
- Class 2
- Regulation
- 21 CFR 878.3550
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Santa Barbara, CA, US
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