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FDA 510(k) Application Details - K020090
Device Classification Name
Introducer, Catheter
More FDA Info for this Device
510(K) Number
K020090
Device Name
Introducer, Catheter
Applicant
THOMAS MEDICAL PRODUCTS, INC.
65 GREAT VALLEY PKWY.
MALVERN, PA 19355 US
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Contact
TIM STOUDT
Other 510(k) Applications for this Contact
Regulation Number
870.1340
More FDA Info for this Regulation Number
Classification Product Code
DYB
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
01/10/2002
Decision Date
02/11/2002
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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