The following data is part of a premarket notification filed by Ferndale Laboratories, Inc. with the FDA for Locobase Wound And Skin Emulsion.
Device ID | K060272 |
510k Number | K060272 |
Device Name: | LOCOBASE WOUND AND SKIN EMULSION |
Classification | Dressing, Wound, Drug |
Applicant | FERNDALE LABORATORIES, INC. 780 WEST EIGHT MILE RD. Ferndale, MI 48220 |
Contact | Richard A Hamer |
Correspondent | Richard A Hamer FERNDALE LABORATORIES, INC. 780 WEST EIGHT MILE RD. 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 | 2006-02-02 |
Decision Date | 2007-01-12 |
Summary: | summary |