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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 K100803
Device Name OLYMPUS FLUSHING PUMP OFP MODEL: OFP-1
Applicant
Keymed, Inc.
11440 W. Bernardo Dr.
Suite 300
San Diego,  CA  92127
Applicant Contact RONALD WARREN
Correspondent
Keymed, Inc.
11440 W. Bernardo Dr.
Suite 300
San Diego,  CA  92127
Correspondent Contact RONALD WARREN
Regulation Number876.1500
Classification Product Code
FEQ  
Date Received03/22/2010
Decision Date 04/22/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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