The following data is part of a premarket notification filed by Changzhou Holymed Products Co Ltd with the FDA for Hm Surgical Gown, Non Reinforced Hm Surgical Gown, Fabric Reinforced Hm Surgical Gown, Polyerinforced.
| Device ID | K121998 |
| 510k Number | K121998 |
| Device Name: | HM SURGICAL GOWN, NON REINFORCED HM SURGICAL GOWN, FABRIC REINFORCED HM SURGICAL GOWN, POLYERINFORCED |
| Classification | Gown, Surgical |
| Applicant | CHANGZHOU HOLYMED PRODUCTS CO LTD 528 CHANGWU ROAD SOUTH WUJIN DISTRICT Changhou, CN 213167 |
| Contact | Alan Yu |
| Correspondent | Alan Yu CHANGZHOU HOLYMED PRODUCTS CO LTD 528 CHANGWU ROAD SOUTH WUJIN DISTRICT Changhou, CN 213167 |
| Product Code | FYA |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-07-09 |
| Decision Date | 2012-12-20 |