SILICONE
FDA 510(k) clearance K844377 · decided 1985-03-18
Clearance details
- K-number
- K844377
- Device name
- SILICONE
- Applicant
- Treace Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1984-11-13
- Decision date
- 1985-03-18
- Days to decision
- 125 days
- Clearance type
- Traditional
- Advisory committee
- Unknown
- Location
- Memphis, TN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.