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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 K103235
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 Received11/02/2010
Decision Date 12/23/2010
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
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