510(k) K945537
- Device
- T-GUARD
- Applicant
- MED ET AL DEVELOPMENT
- 510(k) number
- K945537
- Product code
- LQX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1995-03-23
- Date received
- 1994-11-14
- Regulation
- 890.3475
- Classification name
- Device, Finger-sucking
- Medical specialty
- Physical Medicine
- Review panel
- Dental
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- E ZILBER
- Address
- 815 Tadlock Pl. Matthews NC US 28105 28105
FDA Registration Numbers#
- 3013152643
- 3008317118
- 3026263452
- 3006621348
- 3005343641
- 3042251637
- 3034605486
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code LQX #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K864870 | THUMBSHELPER POWER RING | Levolon Company, Inc. | 1987-02-12 |
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