PERMA FIBER,MODEL 441; PERMA MESH, MODEL 440
FDA 510(k) clearance K082180 · decided 2008-12-17
Clearance details
- K-number
- K082180
- Device name
- PERMA FIBER,MODEL 441; PERMA MESH, MODEL 440
- Applicant
- Angelus Industria DE Productos Odontologicos
- Decision
- Substantially Equivalent
- Date received
- 2008-08-01
- Decision date
- 2008-12-17
- Days to decision
- 138 days
- Clearance type
- Traditional
- Product code
- EBI
- Device class
- 2
- Regulation number
- 872.3760
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- San Diego, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.