The following data is part of a premarket notification filed by Bioplax Limited with the FDA for Aftamed Mouthwash; Aftamed Gel; Aftamed Spray; Aftamed Shield; Aftamed Junior Gel.
| Device ID | K130959 |
| 510k Number | K130959 |
| Device Name: | AFTAMED MOUTHWASH; AFTAMED GEL; AFTAMED SPRAY; AFTAMED SHIELD; AFTAMED JUNIOR GEL |
| Classification | Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic |
| Applicant | BIOPLAX LIMITED 472 S STATE STREET, #101 Bellingham, WA 98225 |
| Contact | Paul Ketteridge |
| Correspondent | Paul Ketteridge BIOPLAX LIMITED 472 S STATE STREET, #101 Bellingham, WA 98225 |
| Product Code | MGQ |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-04-05 |
| Decision Date | 2014-04-04 |
| Summary: | summary |