510(k) K823442
- Device
- FISCH MODIFIED TOTAL OSSICULAR PROSTHES
- Applicant
- TREACE MEDICAL, INC.
- 510(k) number
- K823442
- Product code
- LBM
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1982-12-03
- Date received
- 1982-11-16
- Regulation
- 874.3450
- Classification name
- Porous Polyethylene Ossicular Replacement
- Medical specialty
- Ear Nose & Throat
- Review panel
- Ear Nose & Throat
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 9612501
- 1045254
- 3018094310
- 3017636737
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code LBM #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K823441 | AUSTIN MODIFIED TOTAL OSSICULAR REPLACE | Treace Medical, Inc. | 1982-12-03 |
Legacy Summary#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases
FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases