510(k) K864870
- Device
- THUMBSHELPER POWER RING
- Applicant
- LEVOLON COMPANY, INC.
- 510(k) number
- K864870
- Product code
- LQX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1987-02-12
- Date received
- 1986-12-12
- Regulation
- 890.3475
- Classification name
- Device, Finger-sucking
- Medical specialty
- Physical Medicine
- Review panel
- Dental
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- CHARLES R LEVERETTE
- Address
- 343 Pineridge Dr. Forest Park GA US 30050 30050
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 |
|---|---|---|---|
| K945537 | T-GUARD | Med ET AL Development | 1995-03-23 |
Legacy Summary#
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FDA Review#
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