POREX(TM) SILICONE SURGICAL IMPLANTS FOR E.N.T.
FDA 510(k) clearance K870257 · decided 1987-02-24
Clearance details
- K-number
- K870257
- Device name
- POREX(TM) SILICONE SURGICAL IMPLANTS FOR E.N.T.
- Applicant
- Porex Medical
- Decision
- Substantially Equivalent
- Date received
- 1987-01-23
- Decision date
- 1987-02-24
- Days to decision
- 32 days
- Clearance type
- Traditional
- Advisory committee
- Unknown
- Location
- Fairburn, GA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.