SYSTEM 80 FACEPLATE-IN-THE-EAR #F1
FDA 510(k) clearance K822411 · decided 1983-07-12
Clearance details
- K-number
- K822411
- Device name
- SYSTEM 80 FACEPLATE-IN-THE-EAR #F1
- Applicant
- Western Advanced Technology, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1982-08-10
- Decision date
- 1983-07-12
- Days to decision
- 336 days
- Clearance type
- Traditional
- Product code
- EIB
- Device class
- 1
- Regulation number
- 872.4565
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Mchenry, IL, 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 |
|---|---|---|
| DTF-1000LL,DTF-1000 (K911118) | Cp Medical | 1991-11-20 |
| MODEL OPO-32 IRRIGATION SLEEVE (K874543) | Allergan, Inc. | 1988-01-14 |
| ROBINSON MIDDLE EAR PROSTHESIS (K760570) | Xomed, Inc. | 1976-09-21 |
Recalls involving this device
No recalls on record reference this clearance.