The following data is part of a premarket notification filed by Kunshan Jiehong Nonwoven Product Co., Ltd. with the FDA for Top Drape Sterile, Top Drape-non Sterile, Bottom Drape- Sterile, Bottom Drape.
| Device ID | K112136 |
| 510k Number | K112136 |
| Device Name: | TOP DRAPE STERILE, TOP DRAPE-NON STERILE, BOTTOM DRAPE- STERILE, BOTTOM DRAPE |
| Classification | Drape, Surgical |
| Applicant | KUNSHAN JIEHONG NONWOVEN PRODUCT CO., LTD. 1340 WEST PENNSYLVANIA AVE San Diego, CA 92103 |
| Contact | Glen Feye |
| Correspondent | Glen Feye KUNSHAN JIEHONG NONWOVEN PRODUCT CO., LTD. 1340 WEST PENNSYLVANIA AVE San Diego, CA 92103 |
| Product Code | KKX |
| CFR Regulation Number | 878.4370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-07-26 |
| Decision Date | 2011-09-29 |