The following data is part of a premarket notification filed by Lancaster County Assoc. For The Blind with the FDA for Sheets.
| Device ID | K813551 |
| 510k Number | K813551 |
| Device Name: | SHEETS |
| Classification | Drape, Surgical |
| Applicant | LANCASTER COUNTY ASSOC. FOR THE BLIND 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KKX |
| CFR Regulation Number | 878.4370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-12-21 |
| Decision Date | 1982-01-18 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() SHEETS 88702979 not registered Live/Pending |
AMS Sales & Marketing LLC 2019-11-22 |
![]() SHEETS 85483401 4215478 Dead/Cancelled |
PureBrands, LLC 2011-11-30 |
![]() SHEETS 85220698 4048199 Dead/Cancelled |
PureBrands, LLC 2011-01-19 |
![]() SHEETS 85217115 4112933 Dead/Cancelled |
PureBrands, LLC 2011-01-13 |