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FDA 510(k) Application Details - K043314
Device Classification Name
Washer, Cleaner, Automated, Endoscope
More FDA Info for this Device
510(K) Number
K043314
Device Name
Washer, Cleaner, Automated, Endoscope
Applicant
LANGFORD IC SYSTEMS, INC.
310 S. WILLIAMS BLVD.
SUITE 270
TUCSON, AZ 85711 US
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Contact
TERRY LANGFORD
Other 510(k) Applications for this Contact
Regulation Number
876.1500
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Classification Product Code
NVE
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/01/2004
Decision Date
06/20/2005
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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