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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name pump, air, non-manual, for endoscope
510(k) Number K132340
Device Name ERBEFLO CLEVERCAP HYBRID TUBING/CAP SET FOR PENTAX SCOPES, ERBEFLO CLEVERCAP HYBRID CO2 TUBING/CAP SET FOR OLYMPUS 160/1
Applicant
ERBE USA, INC.
2225 NORTHWEST PKWY.
MARIETTA,  GA  30067
Applicant Contact JOHN TARTAL
Correspondent
REGULATORY TECHNOLOGY SERVICES, LLC
1000 Westgate Drive,
Suite 510k
Saint Paul,  MN  55114
Regulation Number876.1500
Classification Product Code
FEQ  
Date Received07/26/2013
Decision Date 12/17/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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