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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name introducer, catheter
510(k) Number K934901
Device Name TEAR-AWAY SHEATH INTRODUCER SET WITH INTEGRAL HEMOSTASIS VALVE
Original Applicant
THOMAS MEDICAL PRODUCTS, INC.
65 great valley pkwy.
malvern,  PA  19355
Original Contact david g catlin
Regulation Number870.1340
Classification Product Code
DYB  
Date Received10/14/1993
Decision Date 01/21/1994
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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