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FDA 510(k) Application Details - K042647
Device Classification Name
System, Image Processing, Radiological
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510(K) Number
K042647
Device Name
System, Image Processing, Radiological
Applicant
COACTIV, LLC
1100 LAKEVIEW BLVD
DENTON, TX 76208 US
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Contact
CARL ALLETTO
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Regulation Number
892.2050
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Classification Product Code
LLZ
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More FDA Info for this Product Code
Date Received
09/28/2004
Decision Date
10/07/2004
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
RA - Radiology
Review Advisory Committee
RA - Radiology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
Y
Expedited Review
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