The following data is part of a premarket notification filed by Collegium Pharmaceutical Incorporated with the FDA for Hylatopic Emollient Foam.
| Device ID | K083024 |
| 510k Number | K083024 |
| Device Name: | HYLATOPIC EMOLLIENT FOAM |
| Classification | Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic |
| Applicant | COLLEGIUM PHARMACEUTICAL INCORPORATED 400 HIGHLAND CORPORATE DRIVE Cumberland, RI 02864 |
| Contact | Ronald M Gurge |
| Correspondent | Ronald M Gurge COLLEGIUM PHARMACEUTICAL INCORPORATED 400 HIGHLAND CORPORATE DRIVE Cumberland, RI 02864 |
| Product Code | MGQ |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2008-10-09 |
| Decision Date | 2009-03-27 |
| Summary: | summary |