The following data is part of a premarket notification filed by Veratex Corp. with the FDA for Sterile Drape 17x18 W/3 Fenestration.
| Device ID | K801033 |
| 510k Number | K801033 |
| Device Name: | STERILE DRAPE 17X18 W/3 FENESTRATION |
| Classification | Drape, Surgical |
| Applicant | VERATEX CORP. 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 | 1980-05-01 |
| Decision Date | 1980-05-20 |