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FDA 510(k) Application Details - K031346
Device Classification Name
Catheter, Ultrasound, Intravascular
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510(K) Number
K031346
Device Name
Catheter, Ultrasound, Intravascular
Applicant
JOMED, INC.
2870 KILGORE RD.
RANCHO CORDOVA, CA 95670 US
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Contact
LORRY W HUFFMAN
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Regulation Number
870.1200
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Classification Product Code
OBJ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
04/29/2003
Decision Date
06/23/2003
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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