The following data is part of a premarket notification filed by Mpm Medical, Inc. with the FDA for Mpm Regenecare Wound Gel.
Device ID | K992074 |
510k Number | K992074 |
Device Name: | MPM REGENECARE WOUND GEL |
Classification | Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic |
Applicant | MPM MEDICAL, INC. 6401 MEADOWS WEST DR. Fort Worth, TX 76132 |
Contact | Richard A Hamer |
Correspondent | Richard A Hamer MPM MEDICAL, INC. 6401 MEADOWS WEST DR. Fort Worth, TX 76132 |
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 | 1999-06-18 |
Decision Date | 1999-12-23 |
Summary: | summary |