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FDA 510(k) Application Details - K022911
Device Classification Name
System, X-Ray, Fluoroscopic, Image-Intensified
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510(K) Number
K022911
Device Name
System, X-Ray, Fluoroscopic, Image-Intensified
Applicant
INTEGRITY PRACTICE MANAGEMENT, INC.
1104 ENTERPRISE DR.
SIOUX FALLS, SD 57106 US
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Contact
KEVIN J MEURET
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Regulation Number
892.1650
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Classification Product Code
JAA
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More FDA Info for this Product Code
Date Received
09/03/2002
Decision Date
12/02/2002
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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