SEAC ADVANCED DENTAL SYSTEM - MODEL 2001,2010 OR MODEL 2020— 510(k) K974487
Substantially EquivalentAsi Medical, Inc.
FDA 510(k) clearance K974487 for SEAC ADVANCED DENTAL SYSTEM - MODEL 2001,2010 OR MODEL 2020, Substantially Equivalent on 1998-02-18. Applicant: Asi Medical, Inc.. Device class: 1.
Clearance details
- Applicant
- Asi Medical, Inc.
- Product code
- Code EIA
- Device class
- Class 1
- Regulation
- 21 CFR 872.6640
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Centennial, CO, US
Recent devices under product code EIA
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view allRecalls naming K974487
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 K974487.
Data sourced from openFDA. This site is unofficial and independent of the FDA.