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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Needle, Conduction, Anesthetic (W/Wo Introducer)
510(k) Number K191290
Device Name Ancora Nerve Block Catheter Set
Applicant
Ancora Medical Technology
333 Ravenswood Ave.
Menlo Park,  CA  94025
Applicant Contact Chunyuan Qiu
Correspondent
Decus Biomedical, Inc.
2342 Shattuck Ave., #333
Berkeley,  CA  94704
Correspondent Contact Terri Bogucki
Regulation Number868.5150
Classification Product Code
BSP  
Date Received05/13/2019
Decision Date 02/06/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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