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FDA 510(k) Application Details - K000366
Device Classification Name
Stylet, Catheter
More FDA Info for this Device
510(K) Number
K000366
Device Name
Stylet, Catheter
Applicant
ACCUFIX RESEARCH INSTITUTE
12503 E. EUCLID DR. # 20
ENGLEWOOD, CO 80111 US
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Contact
MICHAEL J ANDREWS
Other 510(k) Applications for this Contact
Regulation Number
870.1380
More FDA Info for this Regulation Number
Classification Product Code
DRB
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
02/04/2000
Decision Date
04/14/2000
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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