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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Endoscopic Irrigation/Suction System
510(k) Number K190469
Device Name ERBEFLO 2 Disposable Tubing System
Applicant
Erbe USA, Inc.
2225 Northwest Pkwy.
Marietta,  GA  30067
Applicant Contact John Tartal
Correspondent
Erbe USA, Inc.
2225 Northwest Pkwy.
Marietta,  GA  30067
Correspondent Contact John Tartal
Regulation Number876.1500
Classification Product Code
OCX  
Date Received02/26/2019
Decision Date 05/23/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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