510(k) K781522
- Device
- THE VISUAL SPEECH AID
- Applicant
- EXETER MEDICAL LABS, INC.
- 510(k) number
- K781522
- Product code
- LFA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1978-11-08
- Date received
- 1978-09-05
- Regulation
- 510(k) Premarket Notification
- Classification name
- Aids, Speech Training For The Hearing Impaired (battery-operated Or Non-patient)
- Medical specialty
- 510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices
- Review panel
- Ear Nose & Throat
- Device class
- U
- Clearance type
- Traditional
- Third party reviewed
- No
Related Records
Applicant Contact
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
Source Documents
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code LFA
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K790554 | EXETER LIP SEAL | Exeter Medical Labs, Inc. | 1979-04-10 |
Legacy Summary
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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