FDA 510(k) Application Details - K060458

Device Classification Name Accessories, Cleaning, For Endoscope

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510(K) Number K060458
Device Name Accessories, Cleaning, For Endoscope
Applicant LANGFORD IC SYSTEMS, INC.
141 WASHINGTON STREET
EAST WALPOLE, MA 02032 US
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Contact JIMMIE T JOHNSTON
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Regulation Number 876.1500

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Classification Product Code FEB
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Date Received 02/22/2006
Decision Date 10/12/2006
Decision SESE - SUBST EQUIV
Classification Advisory Committee GU - Gastroenterology & Urology
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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