510(k) K901923
- Device
- INVOTEC POLY-MESH MANDIBULAR TRAY
- Applicant
- INVOTEC INTERNATIONAL, INC.
- 510(k) number
- K901923
- Product code
- JAZ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1990-10-31
- Date received
- 1990-04-30
- 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#
- Contact
- JEFFREY L AULL
- Address
- 11330-1st. John'S Industrial Pkwy. Jacksonville FL US 32216 32216
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 |
|---|---|---|---|
| K821904 | XOMED MANDIBULAR TRAY | Xomed, Inc. | 1982-07-26 |
Legacy Summary#
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FDA Review#
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