The following data is part of a premarket notification filed by Promedical Products Co., Ltd. with the FDA for Promedical Surgical Mayo Stand Covers, Band Bags, Table Covers And Equipment Covers.
| Device ID | K042137 |
| 510k Number | K042137 |
| Device Name: | PROMEDICAL SURGICAL MAYO STAND COVERS, BAND BAGS, TABLE COVERS AND EQUIPMENT COVERS |
| Classification | Drape, Surgical |
| Applicant | PROMEDICAL PRODUCTS CO., LTD. 125 CLEMENTS AVE. Starkville, MS 39759 |
| Contact | Boyd Harris |
| Correspondent | Boyd Harris PROMEDICAL PRODUCTS CO., LTD. 125 CLEMENTS AVE. Starkville, MS 39759 |
| Product Code | KKX |
| CFR Regulation Number | 878.4370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-08-09 |
| Decision Date | 2004-10-05 |