510(k) K952218
- Device
- JT-3 ELECTROGNATHOGRAPH
- Applicant
- BIO-RESEARCH ASSOCIATES, INC.
- 510(k) number
- K952218
- Product code
- NFS
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1995-09-21
- Date received
- 1995-05-11
- Regulation
- 872.2060
- Classification name
- Device, Jaw Tracking, For Monitoring Jaw Positions
- Medical specialty
- Dental
- Review panel
- Dental
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- JOHN C RADKE
- Address
- 4113 N. Port Washington Rd. Milwaukee WI US 53212 53212
FDA Registration Numbers#
- 3009171220
- 3005942449
- 3010455030
- 1410097
- 3031750080
- 3003637274
- 3004982293
- 3014644422
- 9616978
- 2183552
- 3030515618
- 3006098230
- 8010711
- 3010173003
- 3014732
- 3043542875
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code NFS #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K843951 | SIROGNATHOGRAPH | Siemens Medical Solutions USA, Inc. | 1984-11-14 |
Legacy Summary#
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FDA Review#
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