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FDA 510(k) Application Details - K010304
Device Classification Name
System, X-Ray, Mobile
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510(K) Number
K010304
Device Name
System, X-Ray, Mobile
Applicant
IROM IMAGING, INC.
3720 SOUTH LIPAN ST.
ENGLEWOOD, CO 80110 US
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Contact
ROMAN KRYSTYNIAK
Other 510(k) Applications for this Contact
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
02/01/2001
Decision Date
02/12/2001
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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