The following data is part of a premarket notification filed by Johnson & Johnson Consumer Products, Inc. with the FDA for Johnson & Johnson Fluoride Dental Floss, Mint Waxed.
| Device ID | K935440 |
| 510k Number | K935440 |
| Device Name: | JOHNSON & JOHNSON FLUORIDE DENTAL FLOSS, MINT WAXED |
| Classification | Floss, Dental |
| Applicant | JOHNSON & JOHNSON CONSUMER PRODUCTS, INC. GRANDVIEW RD. Skillman, NJ 08558 |
| Contact | James A Haviland |
| Correspondent | James A Haviland JOHNSON & JOHNSON CONSUMER PRODUCTS, INC. GRANDVIEW RD. Skillman, NJ 08558 |
| Product Code | JES |
| CFR Regulation Number | 872.6390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-11-12 |
| Decision Date | 1994-02-03 |
| Summary: | summary |