The following data is part of a premarket notification filed by Glaxosmithkline Consumer Healthcare (gskch) with the FDA for Biotene Oral Balance Gel, Biotene Dry Mouth Oral Rinse, Biotene Moisturizing Mouth Spray.
| Device ID | K123731 |
| 510k Number | K123731 |
| Device Name: | BIOTENE ORAL BALANCE GEL, BIOTENE DRY MOUTH ORAL RINSE, BIOTENE MOISTURIZING MOUTH SPRAY |
| Classification | Saliva, Artificial |
| Applicant | GLAXOSMITHKLINE CONSUMER HEALTHCARE (GSKCH) 1500 LITTLETON ROAD Parsippany, NJ 07054 |
| Contact | Paul Krumm |
| Correspondent | Paul Krumm GLAXOSMITHKLINE CONSUMER HEALTHCARE (GSKCH) 1500 LITTLETON ROAD Parsippany, NJ 07054 |
| Product Code | LFD |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-12-05 |
| Decision Date | 2013-01-04 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00048582004405 | K123731 | 000 |
| 00048582802209 | K123731 | 000 |
| 00048582350410 | K123731 | 000 |
| 00048582285422 | K123731 | 000 |
| 00048582120266 | K123731 | 000 |
| 00048582100077 | K123731 | 000 |
| 00048582004580 | K123731 | 000 |
| 00048582004566 | K123731 | 000 |
| 00048582003309 | K123731 | 000 |