The following data is part of a premarket notification filed by Surgikos, Inc. with the FDA for Barrier Surgical Drapes W/ Drisite* W/microcide*.
| Device ID | K790725 |
| 510k Number | K790725 |
| Device Name: | BARRIER SURGICAL DRAPES W/ DRISITE* W/MICROCIDE* |
| Classification | Drape, Surgical |
| Applicant | SURGIKOS, INC. 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 | 1979-04-13 |
| Decision Date | 1979-05-11 |