The following data is part of a premarket notification filed by Custom Medical Products, Ltd. with the FDA for Abdominal / Thoracic Patient Drape.
| Device ID | K930815 |
| 510k Number | K930815 |
| Device Name: | ABDOMINAL / THORACIC PATIENT DRAPE |
| Classification | Drape, Surgical |
| Applicant | CUSTOM MEDICAL PRODUCTS, LTD. P.O. BOX 8875 Asheville, NC 28814 |
| Contact | Kotula-cook |
| Correspondent | Kotula-cook CUSTOM MEDICAL PRODUCTS, LTD. P.O. BOX 8875 Asheville, NC 28814 |
| Product Code | KKX |
| CFR Regulation Number | 878.4370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-02-17 |
| Decision Date | 1994-05-05 |