The following data is part of a premarket notification filed by Johnson & Johnson Professionals, Inc. with the FDA for Denture Adhesive Seals.
| Device ID | K831493 |
| 510k Number | K831493 |
| Device Name: | DENTURE ADHESIVE SEALS |
| Classification | Carboxymethylcellulose Sodium Or Polyvinyl Methylether Maleic Acid Calcium-sodium |
| Applicant | JOHNSON & JOHNSON PROFESSIONALS, INC. 325 PARAMOUNT DR. Raynham, MA 02767 -0350 |
| Product Code | KOT |
| CFR Regulation Number | 872.3490 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-05-10 |
| Decision Date | 1983-06-30 |