Lab Bag With Fabric Pouch

Laparoscope, General & Plastic Surgery

Advanced Medical Design Co., Ltd.

The following data is part of a premarket notification filed by Advanced Medical Design Co., Ltd. with the FDA for Lab Bag With Fabric Pouch.

Pre-market Notification Details

Device IDK210248
510k NumberK210248
Device Name:Lab Bag With Fabric Pouch
ClassificationLaparoscope, General & Plastic Surgery
Applicant Advanced Medical Design Co., Ltd. 4-5F, No 29, Wuquan 5th Rd., Wugu Dist. New Taipei City,  TW 248018
ContactSilvia Yeh
CorrespondentJose Wang
Advanced Medical Design Co., Ltd. 4-5F, No 29, Wuquan 5th Rd., Wugu Dist. New Taipei City,  TW 248018
Product CodeGCJ  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-01-29
Decision Date2021-07-30

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