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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name laparoscope, general & plastic surgery
510(k) Number K210248
Device Name Lab Bag with Fabric Pouch
Applicant
Advanced Medical Design Co., Ltd.
4-5F, No 29, Wuquan 5th Rd., Wugu Dist.
New Taipei City,  TW 248018
Applicant Contact Silvia Yeh
Correspondent
Advanced Medical Design Co., Ltd.
4-5F, No 29, Wuquan 5th Rd., Wugu Dist.
New Taipei City,  TW 248018
Correspondent Contact Jose Wang
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received01/29/2021
Decision Date 07/30/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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