The following data is part of a premarket notification filed by Mpm Medical, Inc. with the FDA for Regenecare Wound Gel.
| Device ID | K020540 |
| 510k Number | K020540 |
| Device Name: | REGENECARE WOUND GEL |
| Classification | Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic |
| Applicant | MPM MEDICAL, INC. 2301 CROWN COURT Irving, TX 75038 |
| Contact | Paul R Miller |
| Correspondent | Paul R Miller MPM MEDICAL, INC. 2301 CROWN COURT Irving, TX 75038 |
| 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 | 2002-02-19 |
| Decision Date | 2002-11-01 |
| Summary: | summary |