FORTAGEN ORAL MEMBRANE— 510(k) K071555
Substantially EquivalentOrganogenesis, Inc.
FDA 510(k) clearance K071555 for FORTAGEN ORAL MEMBRANE, Substantially Equivalent on 2007-08-30. Applicant: Organogenesis, Inc.. Device class: 2.
Clearance details
- Applicant
- Organogenesis, Inc.
- Product code
- Code NPL
- Device class
- Class 2
- Regulation
- 21 CFR 872.3930
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Canton, MA, US
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