The following data is part of a premarket notification filed by Attwill Medical Solutions with the FDA for Haloguard Protective Disc With Chg.
| Device ID | K200641 |
| 510k Number | K200641 |
| Device Name: | HaloGUARD Protective Disc With CHG |
| Classification | Dressing, Wound, Drug |
| Applicant | ATTWILL Medical Solutions 925 Development Drive Lodi, WI 53555 |
| Contact | Attilio Di Fiore |
| Correspondent | Amarinder S. Gill ATTWILL Medical Solutions 925 Development Drive Lodi, WI 53555 |
| 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 | 2020-03-11 |
| Decision Date | 2020-09-03 |