The following data is part of a premarket notification filed by Deroyal Industries, Inc. with the FDA for Qualtex Neurolok Surgical Sponge.
| Device ID | K884790 |
| 510k Number | K884790 |
| Device Name: | QUALTEX NEUROLOK SURGICAL SPONGE |
| Classification | Gauze/sponge, Internal, X-ray Detectable |
| Applicant | DEROYAL INDUSTRIES, INC. 200 DEBUSK LN. Powell, TN 37849 |
| Contact | Wyatt Zachry |
| Correspondent | Wyatt Zachry DEROYAL INDUSTRIES, INC. 200 DEBUSK LN. Powell, TN 37849 |
| Product Code | GDY |
| CFR Regulation Number | 878.4450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-11-15 |
| Decision Date | 1988-12-09 |