ESTENIA— 510(k) K982164
Substantially EquivalentKuraray America, Inc.
FDA 510(k) clearance K982164 for ESTENIA, Substantially Equivalent on 1998-08-10. Applicant: Kuraray America, Inc.. Device class: 2.
Clearance details
- Applicant
- Kuraray America, Inc.
- Product code
- Code EBF
- Device class
- Class 2
- Regulation
- 21 CFR 872.3690
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- New York, NY, US
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