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FDA 510(k) Application Details - K042368
Device Classification Name
System, X-Ray, Mobile
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510(K) Number
K042368
Device Name
System, X-Ray, Mobile
Applicant
PHILIPS MEDICAL SYSTEMS NORTH AMERICA CO.
22100 BOTHELL EVERETT HIGHWAY
BOTHELL, WA 98021-8431 US
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Contact
LYNN HARMER
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Regulation Number
892.1720
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Classification Product Code
IZL
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More FDA Info for this Product Code
Date Received
08/31/2004
Decision Date
10/04/2004
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
RA - Radiology
Review Advisory Committee
RA - Radiology
Statement / Summary / Purged Status
Summary
Type
Abbreviated
Reviewed By Third Party
N
Expedited Review
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