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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name valvulotome
510(k) Number K190267
Device Name EZE SIT Valvulotome
Applicant
LeMaitre Vascular
63 Second Avenue
burlington,  MA  01803
Applicant Contact john n. bradsher
Correspondent
LeMaitre Vascular
63 Second Avenue
burlington,  MA  01803
Correspondent Contact john n. bradsher
Regulation Number870.4885
Classification Product Code
MGZ  
Date Received02/08/2019
Decision Date 10/30/2019
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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