The following data is part of a premarket notification filed by Questor Pharma, Inc. with the FDA for Quegel Hydrophilic Wound Dressing.
| Device ID | K955400 |
| 510k Number | K955400 |
| Device Name: | QUEGEL HYDROPHILIC WOUND DRESSING |
| Classification | Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic |
| Applicant | QUESTOR PHARMA, INC. 101 ORANGE-CO CIRCLE, N.E. Winter Haven, FL 33881 |
| Contact | Eric J Jolly |
| Correspondent | Eric J Jolly QUESTOR PHARMA, INC. 101 ORANGE-CO CIRCLE, N.E. Winter Haven, FL 33881 |
| 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 | 1995-11-24 |
| Decision Date | 1996-02-09 |