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FDA 510(k) Application Details - K981470
Device Classification Name
System, X-Ray, Mammographic
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510(K) Number
K981470
Device Name
System, X-Ray, Mammographic
Applicant
WORLDWIDE MEDICAL TECHNOLOGIES, LLC
125 MAIN ST., NORTH
WOODBURY, CT 06798-0505 US
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Contact
GARY A LAMOUREUX
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Regulation Number
892.1710
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Classification Product Code
IZH
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More FDA Info for this Product Code
Date Received
04/23/1998
Decision Date
06/19/1998
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
RA - Radiology
Review Advisory Committee
RA - Radiology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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