The following data is part of a premarket notification filed by Swiss American Products, Inc. with the FDA for Elta Wound Cleanser.
| Device ID | K103713 |
| 510k Number | K103713 |
| Device Name: | ELTA WOUND CLEANSER |
| Classification | Dressing, Wound, Drug |
| Applicant | SWISS AMERICAN PRODUCTS, INC. 2055 LUNA RD., STE. 126 Carrollton, TX 75006 |
| Contact | Eric Luo |
| Correspondent | Eric Luo SWISS AMERICAN PRODUCTS, INC. 2055 LUNA RD., STE. 126 Carrollton, TX 75006 |
| 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 | 2010-12-21 |
| Decision Date | 2011-06-16 |