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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 K931587
Device Name MULTI-PORT Y INTRODUCER SET
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 Received03/31/1993
Decision Date 10/06/1993
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
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