1 SERIES MODEL 1 SERIES T2, 1 SERIES X2, 1 SERIES T4, 1 SERIES X4— 510(k) K100378
Substantially EquivalentDaavlin Distributing Co.
FDA 510(k) clearance K100378 for 1 SERIES MODEL 1 SERIES T2, 1 SERIES X2, 1 SERIES T4, 1 SERIES X4, Substantially Equivalent on 2010-04-28. Applicant: Daavlin Distributing Co.. Device class: 2.
Clearance details
- Applicant
- Daavlin Distributing Co.
- Product code
- Code FTC
- Device class
- Class 2
- Regulation
- 21 CFR 878.4630
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Bryan, OH, US
Recent devices under product code FTC
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view allRecalls naming K100378
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K100378.
Data sourced from openFDA. This site is unofficial and independent of the FDA.