The following data is part of a premarket notification filed by Sage Pharmaceuticals, Inc. with the FDA for Panoplex Hydrogel Wound Dressing.
| Device ID | K945005 |
| 510k Number | K945005 |
| Device Name: | PANOPLEX HYDROGEL WOUND DRESSING |
| Classification | Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic |
| Applicant | SAGE PHARMACEUTICALS, INC. 5408 INTERSTATE DR. Shreveport, LA 71109 |
| Contact | William J Roche |
| Correspondent | William J Roche SAGE PHARMACEUTICALS, INC. 5408 INTERSTATE DR. Shreveport, LA 71109 |
| 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 | 1994-10-13 |
| Decision Date | 1995-03-24 |