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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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More FDA Info for this Product Code
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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