The following data is part of a premarket notification filed by Acella Pharmaceuticals, Llc with the FDA for Loutrex Topical Cream.
| Device ID | K120730 |
| 510k Number | K120730 |
| Device Name: | LOUTREX TOPICAL CREAM |
| Classification | Dressing, Wound, Drug |
| Applicant | ACELLA PHARMACEUTICALS, LLC 248 LATITUDE LANE SUITE 104 Lake Wylie, SC 29710 |
| Contact | Lara Noah |
| Correspondent | Lara Noah ACELLA PHARMACEUTICALS, LLC 248 LATITUDE LANE SUITE 104 Lake Wylie, SC 29710 |
| Product Code | FRO |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-03-09 |
| Decision Date | 2012-09-06 |
| Summary: | summary |