The following data is part of a premarket notification filed by Swiss American Products, Inc. with the FDA for Elta Advanced Wound Wash.
| Device ID | K073610 |
| 510k Number | K073610 |
| Device Name: | ELTA ADVANCED WOUND WASH |
| 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 | Yes |
| Date Received | 2007-12-21 |
| Decision Date | 2008-04-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00090205025311 | K073610 | 000 |