The following data is part of a premarket notification filed by Deroyal Industries, Inc. with the FDA for Qualtex Surgical Drape, Modification.
| Device ID | K913486 |
| 510k Number | K913486 |
| Device Name: | QUALTEX SURGICAL DRAPE, MODIFICATION |
| Classification | Drape, Surgical |
| Applicant | DEROYAL INDUSTRIES, INC. 200 DEBUSK LN. Powell, TN 37849 |
| Contact | Debra F Manning |
| Correspondent | Debra F 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 | 1991-08-06 |
| Decision Date | 1992-02-05 |