Surgical Gown (Sterile), Surgical Gown (Non-sterile)

Gown, Surgical

B.J.ZH.F.Panther Medical Equipment CO., LTD.

The following data is part of a premarket notification filed by B.j.zh.f.panther Medical Equipment Co., Ltd. with the FDA for Surgical Gown (sterile), Surgical Gown (non-sterile).

Pre-market Notification Details

Device IDK202706
510k NumberK202706
Device Name:Surgical Gown (Sterile), Surgical Gown (Non-sterile)
ClassificationGown, Surgical
Applicant B.J.ZH.F.Panther Medical Equipment CO., LTD. Floor 3, Building1, 28 Huoju Street, Changping S&T Park, Changping District Beijing,  CN 102200
ContactWenyue Han
CorrespondentDiana Hong
Mid-Link Consulting Co., Ltd P.O. Box. 120-119 Shanghai,  CN 200120
Product CodeFYA  
CFR Regulation Number878.4040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-09-16
Decision Date2020-12-31

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