INION CPS BABY 1.5 BIOABSORBABLE FIXATION SYSTEM
FDA 510(k) clearance K052444 · decided 2005-09-20
Clearance details
- K-number
- K052444
- Device name
- INION CPS BABY 1.5 BIOABSORBABLE FIXATION SYSTEM
- Applicant
- Inion , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2005-09-06
- Decision date
- 2005-09-20
- Days to decision
- 14 days
- Clearance type
- Special
- Product code
- JEY
- Device class
- 2
- Regulation number
- 872.4760
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Tampere, FI
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.