Disposable Specimen Retrieval Bag

Laparoscope, General & Plastic Surgery

Beijing Biosis Healing Biological Technology Co., Ltd.

The following data is part of a premarket notification filed by Beijing Biosis Healing Biological Technology Co., Ltd. with the FDA for Disposable Specimen Retrieval Bag.

Pre-market Notification Details

Device IDK201243
510k NumberK201243
Device Name:Disposable Specimen Retrieval Bag
ClassificationLaparoscope, General & Plastic Surgery
Applicant Beijing Biosis Healing Biological Technology Co., Ltd. No.6 Plant West, Valley No.1 Bio-medicine Industry Park Daxing District Beijing,  CN 102600
ContactJiali Zhou
CorrespondentDiana Hong
Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai,  CN 200120
Product CodeGCJ  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-05-08
Decision Date2020-07-10

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