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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name accessories, cleaning, for endoscope
510(k) Number K152189
Device Name EVOTECH ECR
Applicant
Advanced Sterilization Products (ASP)
33 Technology Dr
Irvine,  CA  92618
Applicant Contact Nazanin Yacobi
Correspondent
Advanced Sterilization Products (ASP)
33 Technology Dr
Irvine,  CA  92618
Correspondent Contact Nazanin R Yacobi
Regulation Number876.1500
Classification Product Code
FEB  
Date Received08/05/2015
Decision Date 07/20/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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