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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 K004025
Device Name SPLITTABLE SHEATH INTRODUCER KIT
Applicant
THOMAS MEDICAL PRODUCTS, INC.
65 GREAT VALLEY PKWY.
MALVERN,  PA  19355
Applicant Contact KIMBERLY A FISCHER
Correspondent
THOMAS MEDICAL PRODUCTS, INC.
65 GREAT VALLEY PKWY.
MALVERN,  PA  19355
Correspondent Contact KIMBERLY A FISCHER
Regulation Number870.1340
Classification Product Code
DYB  
Date Received12/27/2000
Decision Date 07/19/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
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