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FDA 510(k) Application Details - K010187
Device Classification Name
System, X-Ray, Fluoroscopic, Image-Intensified
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510(K) Number
K010187
Device Name
System, X-Ray, Fluoroscopic, Image-Intensified
Applicant
MEDICAL METRICS, INC.
4600 NORTH PARK AVE.
SUITE 100
CHEVY CHASE, MD 20815-4518 US
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Contact
ANN TUNSTALL
Other 510(k) Applications for this Contact
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
01/22/2001
Decision Date
02/14/2001
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
RA - Radiology
Review Advisory Committee
RA - Radiology
Statement / Summary / Purged Status
Statement
Type
Abbreviated
Reviewed By Third Party
N
Expedited Review
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