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FDA 510(k) Application Details - K981131
Device Classification Name
More FDA Info for this Device
510(K) Number
K981131
Device Name
PATHFINDER MOBILE C ARM
Applicant
ACOMA MEDICAL IMAGING, INC.
150 CHADDICK DR.
WHEELING, IL 60090 US
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Contact
JAMES LAMBRECHT
Other 510(k) Applications for this Contact
Regulation Number
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Classification Product Code
OXO
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More FDA Info for this Product Code
Date Received
03/30/1998
Decision Date
06/26/1998
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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