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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 K003731
Device Name SAFESHEATH MSP INTRODUCER SHEATH KIT WITH INTEGRAL HEMOSTASIS VALVE
Original Applicant
THOMAS MEDICAL PRODUCTS, INC.
65 great valley pkwy.
malvern,  PA  19355
Original Contact peter j rapp
Regulation Number870.1340
Classification Product Code
DYB  
Date Received12/04/2000
Decision Date 04/10/2001
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
Recalls CDRH Recalls
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