The following data is part of a premarket notification filed by Laclede, Inc. with the FDA for Oral Balance Liquid/ Gel.
| Device ID | K061331 |
| 510k Number | K061331 |
| Device Name: | ORAL BALANCE LIQUID/ GEL |
| Classification | Saliva, Artificial |
| Applicant | LACLEDE, INC. 2103 EAST UNIVERSITY DR. Rancho Dominquez, CA 90220 |
| Contact | Michael A Pellico |
| Correspondent | Michael A Pellico LACLEDE, INC. 2103 EAST UNIVERSITY DR. Rancho Dominquez, CA 90220 |
| 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 | 2006-05-12 |
| Decision Date | 2006-07-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00048582512016 | K061331 | 000 |