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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name intervertebral fusion device with bone graft, lumbar
510(k) Number K191353
Device Name COMET Lumbar Interbody Fusion Cage
Applicant
BAUI Biotech Co., Ltd.
6F.,No.8, Sec.1, Zongxing Rd., Wugu Dist.,
New Taipei City,  TW 24872
Applicant Contact Jessy Lin
Correspondent
BAUI Biotech Co., Ltd.
6F., No.8, Sec.1, Zongxing Rd., Wugu Dist.,
New Taipei City,  TW 24872
Correspondent Contact Jessy Lin
Regulation Number888.3080
Classification Product Code
MAX  
Date Received05/21/2019
Decision Date 04/14/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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