POREX(TM) EAR PROSTHESIS
FDA 510(k) clearance K863939 · decided 1986-10-24
Clearance details
- K-number
- K863939
- Device name
- POREX(TM) EAR PROSTHESIS
- Applicant
- Porex Medical
- Decision
- Substantially Equivalent
- Date received
- 1986-10-10
- Decision date
- 1986-10-24
- Days to decision
- 14 days
- Clearance type
- Traditional
- Product code
- FZD
- Device class
- 2
- Regulation number
- 878.3590
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Fairburn, GA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| ePTFE-Coated Auricular Implant (K172389) | Implantech Associates, Inc. | 2018-07-18 |
| CANAL WALL PROSTHESIS (K844960) | Richards Medical Co., Inc. | 1985-02-26 |
Recalls involving this device
No recalls on record reference this clearance.