The following data is part of a premarket notification filed by Lodestar Products, Inc. with the FDA for Skin Barrier Film.
| Device ID | K092712 |
| 510k Number | K092712 |
| Device Name: | SKIN BARRIER FILM |
| Classification | Bandage, Liquid |
| Applicant | LODESTAR PRODUCTS, INC. 6833 SAINT LAWRENCE ST. Plano, TX 75024 |
| Contact | Eric Luo |
| Correspondent | Eric Luo LODESTAR PRODUCTS, INC. 6833 SAINT LAWRENCE ST. Plano, TX 75024 |
| Product Code | KMF |
| CFR Regulation Number | 880.5090 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-09-03 |
| Decision Date | 2010-02-23 |