DC ZIRKON— 510(k) K001815
Substantially EquivalentAustenal, Inc.
FDA 510(k) clearance K001815 for DC ZIRKON, Substantially Equivalent on 2000-08-10. Applicant: Austenal, Inc.. Device class: 2.
Clearance details
- Applicant
- Austenal, Inc.
- Product code
- Code EIH
- Device class
- Class 2
- Regulation
- 21 CFR 872.6660
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Chicago, IL, US
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