The following data is part of a premarket notification filed by Gebauer Co. with the FDA for Salivart Oral Moisturizer Model Number 03866-009-75 Salivart Oral Moisturizer Model Number 0386-000-25.
| Device ID | K981693 |
| 510k Number | K981693 |
| Device Name: | SALIVART ORAL MOISTURIZER MODEL NUMBER 03866-009-75 SALIVART ORAL MOISTURIZER MODEL NUMBER 0386-000-25 |
| Classification | Saliva, Artificial |
| Applicant | GEBAUER CO. 9410 ST. CATHERINE AVE. Cleveland, OH 44104 |
| Contact | Denise E Spellman |
| Correspondent | Denise E Spellman GEBAUER CO. 9410 ST. CATHERINE AVE. Cleveland, OH 44104 |
| Product Code | LFD |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-05-13 |
| Decision Date | 2001-08-06 |
| Summary: | summary |