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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Continuous Flush
510(k) Number K152625
Device Name MMS Guide Catheter
Applicant
Micro Medical Solutions, Inc.
790 Willard St. #209
Quincy,  MA  02169
Applicant Contact Gregory Mathison
Correspondent
Micro Medical Solutions, Inc.
790 Willard St. #209
Quincy,  MA  02169
Correspondent Contact Gregory Mathison
Regulation Number870.1210
Classification Product Code
KRA  
Date Received09/15/2015
Decision Date 03/09/2016
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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