The following data is part of a premarket notification filed by Gmax Industries, Inc. with the FDA for Surgical Gown (ae1001, Ae2001, Ae3001); Surgical Gown (ag1001, Ag2001, Ag3001).
| Device ID | K172987 |
| 510k Number | K172987 |
| Device Name: | Surgical Gown (AE1001, AE2001, AE3001); Surgical Gown (AG1001, AG2001, AG3001) |
| Classification | Gown, Surgical |
| Applicant | GMAX Industries, Inc. 2150 Joshua S Path suite 205 Hauppauge, NY 11788 |
| Contact | Julia Huang |
| Correspondent | Diana Hong Mid-Link Consulting Co., Ltd P.O.Box 120-119 Shanghai, CN 200120 |
| Product Code | FYA |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-09-27 |
| Decision Date | 2018-07-13 |
| Summary: | summary |