The following data is part of a premarket notification filed by Richard Hamer Assoc., Inc. with the FDA for Mpm Hydrogel Dressing.
Device ID | K950934 |
510k Number | K950934 |
Device Name: | MPM HYDROGEL DRESSING |
Classification | Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic |
Applicant | RICHARD HAMER ASSOC., INC. 100 EAST 15TH ST. SUITE 320 Fort Worth, TX 76102 |
Contact | Richard A Hamer |
Correspondent | Richard A Hamer RICHARD HAMER ASSOC., INC. 100 EAST 15TH ST. SUITE 320 Fort Worth, TX 76102 |
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 | 1995-03-01 |
Decision Date | 1995-05-16 |