The following data is part of a premarket notification filed by Igi Laboratories, Inc. with the FDA for Dermiseb Cream.
| Device ID | K123724 |
| 510k Number | K123724 |
| Device Name: | DERMISEB CREAM |
| Classification | Dressing, Wound, Drug |
| Applicant | IGI LABORATORIES, INC. 105 LINCOLN AVE. P.O. BOX 687 Buena, NJ 08310 |
| Contact | Frederick Weiss |
| Correspondent | Frederick Weiss IGI LABORATORIES, INC. 105 LINCOLN AVE. P.O. BOX 687 Buena, NJ 08310 |
| 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 | 2012-12-04 |
| Decision Date | 2013-08-28 |
| Summary: | summary |