510(k) K012070
- Device
- ORALLITE COMPREHENSIVE EXAM TRAY
- Applicant
- TRYLON CORP.
- 510(k) number
- K012070
- Product code
- MPU
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2001-11-27
- Date received
- 2001-07-02
- Regulation
- 884.4530
- Classification name
- Source, Chemiluminescent Light
- Medical specialty
- Obstetrics/Gynecology
- Review panel
- Obstetrics/Gynecology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- MARTIN L LONKY
- Address
- 970 W. 190th St., Suite 850 Torrance CA US 90502 90502
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code MPU #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K963391 | SPECULITE | Trylon Corp. | 1997-12-12 |
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