The following data is part of a premarket notification filed by Custom Medical Products, Ltd. with the FDA for Surgical Gown.
| Device ID | K926519 |
| 510k Number | K926519 |
| Device Name: | SURGICAL GOWN |
| Classification | Gown, Surgical |
| 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 | FYA |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-12-30 |
| Decision Date | 1993-08-12 |