FLUOREVER PIT AND FISSURE SEALANT OR FLUOREVER PFS— 510(k) K890494
Substantially EquivalentMacrochem Corp.
FDA 510(k) clearance K890494 for FLUOREVER PIT AND FISSURE SEALANT OR FLUOREVER PFS, Substantially Equivalent on 1989-03-29. Applicant: Macrochem Corp.. Device class: 2.
Clearance details
- Applicant
- Macrochem Corp.
- Product code
- Code EBC
- Device class
- Class 2
- Regulation
- 21 CFR 872.3765
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Billerica, MA, US
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