The following data is part of a premarket notification filed by Smithkline Beecham Consumer Healthcare Products with the FDA for Aquafresh Plaque Fighting Gum.
| Device ID | K944575 |
| 510k Number | K944575 |
| Device Name: | AQUAFRESH PLAQUE FIGHTING GUM |
| Classification | Agent, Polishing, Abrasive, Oral Cavity |
| Applicant | SMITHKLINE BEECHAM CONSUMER HEALTHCARE PRODUCTS 1500 LITTLETON RD. Parsippany, NJ 07054 |
| Contact | Anthony G Amitrano |
| Correspondent | Anthony G Amitrano SMITHKLINE BEECHAM CONSUMER HEALTHCARE PRODUCTS 1500 LITTLETON RD. Parsippany, NJ 07054 |
| Product Code | EJR |
| CFR Regulation Number | 872.6030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-09-19 |
| Decision Date | 1994-12-15 |