510(k) K981693 ยท LFD Saliva, Artificial
SALIVART ORAL MOISTURIZER MODEL NUMBER 03866-009-75 SALIVART ORAL MOISTURIZER MODEL NUMBER 0386-000-25
| Applicant | Gebauer Co., Cleveland OH, US |
| Decision | Substantially Equivalent, Aug 6, 2001 |
| Received | May 13, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K981693
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 20, 2007 | Gebauer Company Salivart Oral Moisturizer, packaged in 2.5 fluid ounce (73.9 mL) spray cans, Part Number: 0386-0009-75; Manufactured by Gebauer Company, Cleveland, Ohio Terminated |
LFD | None listed |
| Jul 20, 2004 | Gebauer Co Salvart Oral Moisturizer, 2.5 fl.oz. aerosol cans, OTC, Item Number 0386-0009-75. Distributed by: Gebauer Co., Cleveland, OH. Terminated |
LFD | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.