The following data is part of a premarket notification filed by Ascent Consumer Products, Inc. with the FDA for Saline Wound Wash, Stericleanse(tm).
| Device ID | K183662 |
| 510k Number | K183662 |
| Device Name: | Saline Wound Wash, SteriCleanse(TM) |
| Classification | Dressing, Wound, Drug |
| Applicant | Ascent Consumer Products, Inc. 105 Baylis Road Melville, NY 11747 |
| Contact | Matthew Kornberg |
| Correspondent | Carey B. Bottom Ascent Consumer Products, Inc. 105 Baylis Road Melville, NY 11747 |
| 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 | 2018-12-27 |
| Decision Date | 2019-09-12 |
| Summary: | summary |