INVOTEC POLY-MESH MANDIBULAR TRAY
FDA 510(k) clearance K901923 · decided 1990-10-31
Clearance details
- K-number
- K901923
- Device name
- INVOTEC POLY-MESH MANDIBULAR TRAY
- Applicant
- Invotec International, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1990-04-30
- Decision date
- 1990-10-31
- Days to decision
- 184 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
- Jacksonville, FL, 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 |
|---|---|---|
| XOMED MANDIBULAR TRAY (K821904) | Xomed, Inc. | 1982-07-26 |
Recalls involving this device
No recalls on record reference this clearance.