The following data is part of a premarket notification filed by Mpm Medical, Inc. with the FDA for Oramagic Plus Oral Wound Rinse.
| Device ID | K060340 |
| 510k Number | K060340 |
| Device Name: | ORAMAGIC PLUS ORAL WOUND RINSE |
| Classification | Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic |
| Applicant | MPM MEDICAL, INC. 897 CHANCERY CT Monroe, MI 48161 |
| Contact | Richard A Hamer |
| Correspondent | Richard A Hamer MPM MEDICAL, INC. 897 CHANCERY CT Monroe, MI 48161 |
| Product Code | MGQ |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2006-02-10 |
| Decision Date | 2006-05-10 |
| Summary: | summary |