The following data is part of a premarket notification filed by Deroyal Industries, Inc. with the FDA for Deroyal Gowns, Sterile, Non-sterile.
| Device ID | K030364 |
| 510k Number | K030364 |
| Device Name: | DEROYAL GOWNS, STERILE, NON-STERILE |
| Classification | Gown, Surgical |
| Applicant | DEROYAL INDUSTRIES, INC. 200 DEBUSK LN. Powell, TN 37849 |
| Contact | Audrey Daniels |
| Correspondent | Audrey Daniels DEROYAL INDUSTRIES, INC. 200 DEBUSK LN. Powell, TN 37849 |
| Product Code | FYA |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-02-04 |
| Decision Date | 2003-04-28 |