The following data is part of a premarket notification filed by Deroyal Industries, Inc. with the FDA for Qualtex Surgical Drape.
| Device ID | K904960 |
| 510k Number | K904960 |
| Device Name: | QUALTEX SURGICAL DRAPE |
| Classification | Drape, Surgical |
| Applicant | DEROYAL INDUSTRIES, INC. 200 DEBUSK LN. Powell, TN 37849 |
| Contact | Debra Manning |
| Correspondent | Debra Manning DEROYAL INDUSTRIES, INC. 200 DEBUSK LN. Powell, TN 37849 |
| Product Code | KKX |
| CFR Regulation Number | 878.4370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-11-05 |
| Decision Date | 1990-12-13 |