XOMED MANDIBULAR TRAY
FDA 510(k) clearance K821904 · decided 1982-07-26
Clearance details
- K-number
- K821904
- Device name
- XOMED MANDIBULAR TRAY
- Applicant
- Xomed, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1982-06-28
- Decision date
- 1982-07-26
- Days to decision
- 28 days
- Clearance type
- Traditional
- Product code
- JAZ
- Device class
- 2
- Regulation number
- 874.3695
- Medical specialty
- Ear, Nose, Throat
- Advisory committee
- Ear, Nose, Throat
- Location
- Arnold, MO, 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 |
|---|---|---|
| INVOTEC POLY-MESH MANDIBULAR TRAY (K901923) | Invotec International, Inc. | 1990-10-31 |
Recalls involving this device
No recalls on record reference this clearance.