The following data is part of a premarket notification filed by Shandong Zhushi Pharmaceutical Group Co., Ltd with the FDA for Disposable Surgical Gown.
Device ID | K210510 |
510k Number | K210510 |
Device Name: | Disposable Surgical Gown |
Classification | Gown, Surgical |
Applicant | Shandong Zhushi Pharmaceutical Group Co., Ltd No.6 Shande Road, Shan County Heze, CN 274300 |
Contact | Junhui Zhu |
Correspondent | Boyle Wang Shanghai Truthful Information Technology Co., Ltd. Room 608, No.738, Shangcheng Rd., Pudong 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 | 2021-02-22 |
Decision Date | 2021-08-12 |