SALIVART ORAL MOISTURIZER MODEL NUMBER 03866-009-75 SALIVART ORAL MOISTURIZER MODEL NUMBER 0386-000-25
FDA 510(k) clearance K981693 · decided 2001-08-06
Clearance details
- K-number
- K981693
- Device name
- SALIVART ORAL MOISTURIZER MODEL NUMBER 03866-009-75 SALIVART ORAL MOISTURIZER MODEL NUMBER 0386-000-25
- Applicant
- Gebauer Co.
- Decision
- Substantially Equivalent
- Date received
- 1998-05-13
- Decision date
- 2001-08-06
- Days to decision
- 1181 days
- Clearance type
- Traditional
- Product code
- LFD
- Device class
- U
- Medical specialty
- Unknown
- Advisory committee
- Unknown
- Location
- Cleveland, OH, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Salivart Oral Moisturizer, packaged in 2.5 fluid ounce (73.9 mL) spray cans, Part Number: recall (Z-0497-2007) | Gebauer Company | 2007-03-20 |
| Salvart Oral Moisturizer, 2.5 fl.oz. aerosol cans, OTC, Item Number 0386-0009-75. Distribu recall (Z-0641-04) | Gebauer Co | 2004-07-20 |