SALITRON SYSTEM
FDA premarket approval P860067 · decided 1988-05-17
Approval details
- PMA number
- P860067
- Trade name
- SALITRON SYSTEM
- Generic name
- Stimulator, salivary system
- Applicant
- Biosonics, Inc.
- Date received
- 1986-12-19
- Decision date
- 1988-05-17
- Days to decision
- 515 days
- Decision code
- APPR
- Product code
- LTF
- Advisory committee
- Dental
- Expedited review
- No
- Location
- Fort Washington, PA
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| ANOTRON(R) INCONTINENCE CONTROL SYSTEM (K882555) | Biosonics, Inc. | 1988-08-30 |
| THE BIOSONICS CONTINENCE CONTROL SYSTEM CCS(TM) (K864448) | Biosonics, Inc. | 1987-02-06 |
| BIOSOICS SPHINCTER TRAINING SYSTEM (K862683) | Biosonics, Inc. | 1986-11-12 |