NORTHWESTERN VOICE RESTORATION KIT
FDA 510(k) clearance K811428 · decided 1981-06-16
Clearance details
- K-number
- K811428
- Device name
- NORTHWESTERN VOICE RESTORATION KIT
- Applicant
- Universal Prosthetics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1981-05-22
- Decision date
- 1981-06-16
- Days to decision
- 25 days
- Clearance type
- Traditional
- Product code
- KAC
- Device class
- 1
- Regulation number
- 874.4420
- Medical specialty
- Ear, Nose, Throat
- Advisory committee
- Ear, Nose, Throat
- 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 |
|---|---|---|
| BARTON-MAYO TRACHEOSTOMA BUTTON (K901377) | Medical Innovations International, Inc. | 1990-06-14 |
| LARYNGECTOMY TUBE (K873992) | Portex, Inc. | 1988-03-24 |
| SHILEY LARYNGECTOMY TUBE (K821993) | Shiley, Inc. | 1982-08-12 |
Recalls involving this device
No recalls on record reference this clearance.