The following data is part of a premarket notification filed by Collegium Pharmaceutical Incorporated with the FDA for Hylatopic Plus Emollient Foam.
| Device ID | K093051 |
| 510k Number | K093051 |
| Device Name: | HYLATOPIC PLUS EMOLLIENT FOAM |
| Classification | Dressing, Wound, Drug |
| 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 | FRO |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2009-09-30 |
| Decision Date | 2009-12-07 |
| Summary: | summary |