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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 K000948
Device Name OLYMPUS ENDOSCOPIC FLUSHING PUMP MODEL OFP-1
Applicant
Keymed (Medical & Industrial Equipment), Ltd.
Stock Rd.
Southend-On-Sea, Essex,  GB SS2 5QH
Applicant Contact ROGER GRAY
Correspondent
Keymed (Medical & Industrial Equipment), Ltd.
Stock Rd.
Southend-On-Sea, Essex,  GB SS2 5QH
Correspondent Contact ROGER GRAY
Regulation Number876.1500
Classification Product Code
FEQ  
Date Received03/23/2000
Decision Date 05/12/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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