ADDITIONAL CLAIMS TO DENTAL RESTORATIVE COMP. KIT— 510(k) K880562
Substantially Equivalent for Some IndicationsMacrochem Corp.
FDA 510(k) clearance K880562 for ADDITIONAL CLAIMS TO DENTAL RESTORATIVE COMP. KIT, Substantially Equivalent for Some Indications on 1988-08-19. Applicant: Macrochem Corp.. Device class: 2.
Clearance details
- Applicant
- Macrochem Corp.
- Product code
- Code DYH
- Device class
- Class 2
- Regulation
- 21 CFR 872.3750
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent for Some Indications
- Clearance type
- Traditional
- Location
- Woburn, MA, US
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