The following data is part of a premarket notification filed by Guangzhou Fortunique Ltd. with the FDA for Guangzhou Fortunique Drapes, Bags And Covers.
| Device ID | K041501 |
| 510k Number | K041501 |
| Device Name: | GUANGZHOU FORTUNIQUE DRAPES, BAGS AND COVERS |
| Classification | Cover, Barrier, Protective |
| Applicant | GUANGZHOU FORTUNIQUE LTD. 485 LAROE ROAD Chester, NY 10918 |
| Contact | Jane B Campbell |
| Correspondent | Jane B Campbell GUANGZHOU FORTUNIQUE LTD. 485 LAROE ROAD Chester, NY 10918 |
| Product Code | MMP |
| CFR Regulation Number | 878.4370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-06-07 |
| Decision Date | 2004-11-30 |
| Summary: | summary |