THE VISUAL SPEECH AID
FDA 510(k) clearance K781522 · decided 1978-11-08
Clearance details
- K-number
- K781522
- Device name
- THE VISUAL SPEECH AID
- Applicant
- Exeter Medical Labs, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1978-09-05
- Decision date
- 1978-11-08
- Days to decision
- 64 days
- Clearance type
- Traditional
- Product code
- LFA
- Device class
- U
- Medical specialty
- Unknown
- Advisory committee
- Unknown
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| EXETER LIP SEAL (K790554) | Exeter Medical Labs, Inc. | 1979-04-10 |
Recalls involving this device
No recalls on record reference this clearance.