The following data is part of a premarket notification filed by Custom Medical Products, Ltd. with the FDA for Surgical Drape And Gown Tray.
| Device ID | K931456 |
| 510k Number | K931456 |
| Device Name: | SURGICAL DRAPE AND GOWN TRAY |
| Classification | Gown, Surgical |
| Applicant | CUSTOM MEDICAL PRODUCTS, LTD. P.O. BOX 8875 Asheville, NC 28814 |
| Contact | Carolann Kotula-cook |
| Correspondent | Carolann Kotula-cook CUSTOM MEDICAL PRODUCTS, LTD. P.O. BOX 8875 Asheville, NC 28814 |
| Product Code | FYA |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-03-23 |
| Decision Date | 1994-07-08 |