The following data is part of a premarket notification filed by Deroyal with the FDA for Deroyal Surgical Gowns, Sterile, Non-sterile.
| Device ID | K033057 |
| 510k Number | K033057 |
| Device Name: | DEROYAL SURGICAL GOWNS, STERILE, NON-STERILE |
| Classification | Gown, Surgical |
| Applicant | DEROYAL 200 DEBUSK LN. Powell, TN 37849 |
| Contact | Sharon Cook |
| Correspondent | Sharon Cook DEROYAL 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 | 2003-09-29 |
| Decision Date | 2003-11-20 |
| Summary: | summary |