The following data is part of a premarket notification filed by Custom Medical Products, Ltd. with the FDA for Custom Procedure Medical Tray Or Kit.
| Device ID | K931844 |
| 510k Number | K931844 |
| Device Name: | CUSTOM PROCEDURE MEDICAL TRAY OR KIT |
| Classification | General Surgery Tray |
| Applicant | CUSTOM MEDICAL PRODUCTS, LTD. P.O. BOX 8875 Asheville, NC 28814 |
| Contact | Allen B Morlock |
| Correspondent | Allen B Morlock CUSTOM MEDICAL PRODUCTS, LTD. P.O. BOX 8875 Asheville, NC 28814 |
| Product Code | LRO |
| CFR Regulation Number | 878.4370 [🔎] |
| Decision | Substantially Equivalent - Kit With Drugs (SEKD) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-04-13 |
| Decision Date | 1994-01-25 |