FDA 510(k) Application Details - K934901

Device Classification Name Introducer, Catheter

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510(K) Number K934901
Device Name Introducer, Catheter
Applicant THOMAS MEDICAL PRODUCTS, INC.
65 GREAT VALLEY PKWY.
MALVERN, PA US
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Contact DAVID G CATLIN
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Regulation Number 870.1340

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Classification Product Code DYB
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Date Received 10/14/1993
Decision Date 01/21/1994
Decision SE - Substantially Equivalent
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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