The following data is part of a premarket notification filed by Nanoplas, Inc. with the FDA for Saline Wound Wash.
| Device ID | K112666 |
| 510k Number | K112666 |
| Device Name: | SALINE WOUND WASH |
| Classification | Dressing, Wound, Drug |
| Applicant | NANOPLAS, INC. 2140 TOUHY AVE Elk Grove Village, IL 60007 |
| Contact | Ryan Lytle |
| Correspondent | Ryan Lytle NANOPLAS, INC. 2140 TOUHY AVE Elk Grove Village, IL 60007 |
| 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 | 2011-09-13 |
| Decision Date | 2012-04-20 |