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 |