The following data is part of a premarket notification filed by Medical Polymers, Inc. with the FDA for Mpi Denture Adhesive Film Seals.
| Device ID | K941365 |
| 510k Number | K941365 |
| Device Name: | MPI DENTURE ADHESIVE FILM SEALS |
| Classification | Carboxymethylcellulose Sodium Or Polyvinyl Methylether Maleic Acid Calcium-sodium |
| Applicant | MEDICAL POLYMERS, INC. 8920 BUSINESS PARK DR. SUITE 290 Austin, TX 78759 |
| Contact | Thomas Vanne |
| Correspondent | Thomas Vanne MEDICAL POLYMERS, INC. 8920 BUSINESS PARK DR. SUITE 290 Austin, TX 78759 |
| Product Code | KOT |
| CFR Regulation Number | 872.3490 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-03-21 |
| Decision Date | 1994-04-22 |