The following data is part of a premarket notification filed by Molnlycke Health Care, Inc. with the FDA for Normlgel 0.9% Isotonic Saline Gel.
| Device ID | K984368 |
| 510k Number | K984368 |
| Device Name: | NORMLGEL 0.9% ISOTONIC SALINE GEL |
| Classification | Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic |
| Applicant | MOLNLYCKE HEALTH CARE, INC. 500 BALDWIN TOWER Eddystone, PA 19022 |
| Contact | Miguel A Negron |
| Correspondent | Miguel A Negron MOLNLYCKE HEALTH CARE, INC. 500 BALDWIN TOWER Eddystone, PA 19022 |
| 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 | 1998-12-07 |
| Decision Date | 1999-02-22 |
| Summary: | summary |