PLASMALUXLS— 510(k) K100628
Substantially EquivalentDaavlin Distributing Co.
FDA 510(k) clearance K100628 for PLASMALUXLS, Substantially Equivalent on 2010-11-24. Applicant: Daavlin Distributing Co.. Device class: 2.
Clearance details
- Applicant
- Daavlin Distributing Co.
- Product code
- Code ONE
- Device class
- Class 2
- Regulation
- 21 CFR 878.4810
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Bryan, OH, US
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