The following data is part of a premarket notification filed by Veratex Corp. with the FDA for Sterile Cotton Rolls #3, 1 1/2.
| Device ID | K830175 |
| 510k Number | K830175 |
| Device Name: | STERILE COTTON ROLLS #3, 1 1/2 |
| Classification | Cotton, Roll |
| Applicant | VERATEX CORP. 803 N. Front St. Suite 3 McHenry, IL 60050 |
| Product Code | EFN |
| CFR Regulation Number | 872.6050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-01-18 |
| Decision Date | 1983-02-18 |