The following data is part of a premarket notification filed by Mpm Medical, Inc. with the FDA for Mpm Hydrogel.
Device ID | K942798 |
510k Number | K942798 |
Device Name: | MPM HYDROGEL |
Classification | Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic |
Applicant | MPM MEDICAL, INC. P.O. BOX 16598 Ft. Worth, TX 76162 -0598 |
Contact | Richard A Hamer |
Correspondent | Richard A Hamer MPM MEDICAL, INC. P.O. BOX 16598 Ft. Worth, TX 76162 -0598 |
Product Code | MGQ |
CFR Regulation Number | 510(k) Premarket Notification [🔎] |
Decision | Substantially Equivalent For Some Indications (SN) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-06-15 |
Decision Date | 1994-07-11 |