The following data is part of a premarket notification filed by Changzhou Holymed Products Co Ltd with the FDA for Hm Surgical Drapes Hm Surgical Equipment Cover.
| Device ID | K122000 |
| 510k Number | K122000 |
| Device Name: | HM SURGICAL DRAPES HM SURGICAL EQUIPMENT COVER |
| Classification | Drape, 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 | KKX |
| CFR Regulation Number | 878.4370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-07-09 |
| Decision Date | 2012-12-12 |