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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 K190369
Device Name M-Y Sheath
Applicant
Ram Medical Innovations, Inc.
326 Braytonburne Dr.
Springfield,  OH  45503
Applicant Contact Mubin Syed
Correspondent
Lamamed Solutions, Inc.
709 Sandoval Way
Hayward,  CA  94544
Correspondent Contact Lloyd H Griese
Regulation Number870.1340
Classification Product Code
DYB  
Date Received02/15/2019
Decision Date 04/17/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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