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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 K100899
Device Name OLYMPUS ENDOSCOPIC FLUSHING PUMP, MODEL OPF-2
Applicant
KEYMED (MEDICAL & INDUSTRIAL EQUIPMENT), LTD.
11440 WEST BERNARDO DRIVE
SUITE 300
SAN DIEGO,  CA  92127
Applicant Contact RON WARREN
Correspondent
KEYMED (MEDICAL & INDUSTRIAL EQUIPMENT), LTD.
11440 WEST BERNARDO DRIVE
SUITE 300
SAN DIEGO,  CA  92127
Correspondent Contact RON WARREN
Regulation Number876.1500
Classification Product Code
FEQ  
Date Received03/31/2010
Decision Date 09/13/2010
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
Recalls CDRH Recalls
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