AUROFLUID PLUS— 510(k) K013505
Substantially EquivalentMetalor Technologies USA
FDA 510(k) clearance K013505 for AUROFLUID PLUS, Substantially Equivalent on 2001-12-19. Applicant: Metalor Technologies USA. Device class: 2.
Clearance details
- Applicant
- Metalor Technologies USA
- 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
- North Attleborough, MA, US
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