The following data is part of a premarket notification filed by Cobes Industries Co., Ltd. with the FDA for Surgical Gown.
| Device ID | K141606 |
| 510k Number | K141606 |
| Device Name: | SURGICAL GOWN |
| Classification | Gown, Surgical |
| Applicant | COBES INDUSTRIES CO., LTD. 23 DENGLIANG ROAD HANKING CENTER 7E-011 Shenzhen, Guangdong, CN 518052 |
| Contact | Lynn Fu |
| Correspondent | Lynn Fu COBES INDUSTRIES CO., LTD. 23 DENGLIANG ROAD HANKING CENTER 7E-011 Shenzhen, Guangdong, CN 518052 |
| Product Code | FYA |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-06-16 |
| Decision Date | 2014-11-17 |