The following data is part of a premarket notification filed by Scivolutions, Inc with the FDA for Scivolutions Various Antibacterial Bandages.
| Device ID | K020318 |
| 510k Number | K020318 |
| Device Name: | SCIVOLUTIONS VARIOUS ANTIBACTERIAL BANDAGES |
| Classification | Tape And Bandage, Adhesive (with Disinfectant) |
| Applicant | SCIVOLUTIONS, INC 962 ALLEGRO LN. Apollo Beach, FL 33572 |
| Contact | Art Ward |
| Correspondent | Art Ward SCIVOLUTIONS, INC 962 ALLEGRO LN. Apollo Beach, FL 33572 |
| Product Code | MXE |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-01-30 |
| Decision Date | 2003-02-03 |
| Summary: | summary |