FDA 510(k) Application Details - K000948

Device Classification Name Pump, Air, Non-Manual, For Endoscope

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510(K) Number K000948
Device Name Pump, Air, Non-Manual, For Endoscope
Applicant KEYMED (MEDICAL & INDUSTRIAL EQUIPMENT), LTD.
STOCK RD.
SOUTHEND-ON-SEA, ESSEX SS25QH GB
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Contact ROGER GRAY
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Regulation Number 876.1500

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Classification Product Code FEQ
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Date Received 03/23/2000
Decision Date 05/12/2000
Decision SESE - SUBST EQUIV
Classification Advisory Committee GU - Gastroenterology & Urology
Review Advisory Committee GU - Gastroenterology & Urology
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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