The following data is part of a premarket notification filed by Kunshan Jiehong Nonwoven Product Co., Ltd. with the FDA for Jie+hong Medical Surgical Gowns - Sterile, Jie+hong Medical Surgical Gowns - Non Sterile.
| Device ID | K111067 |
| 510k Number | K111067 |
| Device Name: | JIE+HONG MEDICAL SURGICAL GOWNS - STERILE, JIE+HONG MEDICAL SURGICAL GOWNS - NON STERILE |
| Classification | Gown, 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 | FYA |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-04-18 |
| Decision Date | 2011-08-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00616784819532 | K111067 | 000 |
| 00616784819433 | K111067 | 000 |
| 00616784819334 | K111067 | 000 |
| 00616784819235 | K111067 | 000 |