RD-3008— 510(k) K011036
Substantially EquivalentHeraeus Kulzer, Inc.
FDA 510(k) clearance K011036 for RD-3008, Substantially Equivalent on 2001-05-10. Applicant: Heraeus Kulzer, Inc.. Device class: 2.
Clearance details
- Applicant
- Heraeus Kulzer, Inc.
- Product code
- Code EJT
- Device class
- Class 2
- Regulation
- 21 CFR 872.3060
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Armonk, NY, US
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