510(k) K821904
- Device
- XOMED MANDIBULAR TRAY
- Applicant
- XOMED, INC.
- 510(k) number
- K821904
- Product code
- JAZ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1982-07-26
- Date received
- 1982-06-28
- Regulation
- 874.3695
- Classification name
- Prosthesis, Facial, Mandibular Implant
- Medical specialty
- Ear Nose & Throat
- Review panel
- Ear Nose & Throat
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 1318 Lonedell Rd. Arnold MO US 63010 63010
FDA Registration Numbers#
- 2029275
- 2028924
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code JAZ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K901923 | INVOTEC POLY-MESH MANDIBULAR TRAY | Invotec International, Inc. | 1990-10-31 |
Legacy Summary#
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FDA Review#
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