The following data is part of a premarket notification filed by Gri Medical & Electronic Technology Co., Ltd. with the FDA for Gri Sterile And Non-sterile Surgical Drapes And Surgical Equipment Covers.
| Device ID | K111458 |
| 510k Number | K111458 |
| Device Name: | GRI STERILE AND NON-STERILE SURGICAL DRAPES AND SURGICAL EQUIPMENT COVERS |
| Classification | Drape, Surgical |
| Applicant | GRI MEDICAL & ELECTRONIC TECHNOLOGY CO., LTD. 717 LAKEGLEN DRIVE Suwanee, GA 30024 |
| Contact | Penny Northcutt |
| Correspondent | Penny Northcutt GRI MEDICAL & ELECTRONIC TECHNOLOGY CO., LTD. 717 LAKEGLEN DRIVE Suwanee, GA 30024 |
| Product Code | KKX |
| CFR Regulation Number | 878.4370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-05-26 |
| Decision Date | 2011-12-01 |
| Summary: | summary |