The following data is part of a premarket notification filed by Ferndale Pharma Group, Inc. with the FDA for Eletone Cream.
| Device ID | K092297 |
| 510k Number | K092297 |
| Device Name: | ELETONE CREAM |
| Classification | Dressing, Wound, Drug |
| Applicant | FERNDALE PHARMA GROUP, INC. 780 W. 8 MILE ROAD Ferndale, MI 48220 |
| Contact | Richard A Hamer |
| Correspondent | Richard A Hamer FERNDALE PHARMA GROUP, INC. 780 W. 8 MILE ROAD Ferndale, MI 48220 |
| 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 | 2009-07-29 |
| Decision Date | 2009-10-09 |
| Summary: | summary |