The following data is part of a premarket notification filed by Cobes Industries Co., Ltd. with the FDA for Surgical Gown (eo Sterilized).
| Device ID | K112796 |
| 510k Number | K112796 |
| Device Name: | SURGICAL GOWN (EO STERILIZED) |
| Classification | Gown, Surgical |
| Applicant | COBES INDUSTRIES CO., LTD. 3500 SOUTH DUPONT HIGHWAY Dover, DE 19901 |
| Contact | Leon Lu |
| Correspondent | Leon Lu COBES INDUSTRIES CO., LTD. 3500 SOUTH DUPONT HIGHWAY Dover, DE 19901 |
| Product Code | FYA |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-09-26 |
| Decision Date | 2013-09-12 |