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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Conduction, Anesthetic
510(k) Number K200624
Device Name Percutaneous Introducer
Applicant
Epimed International, Inc.
13958 Diplomat Dr.
Farmers Branch,  TX  75234
Applicant Contact Preston Frasier
Correspondent
Regulatory Technology Services, LLC
1000 Westgate Dr. Suite #510k
Saint Paul,  MN  55114
Correspondent Contact Mark Job
Regulation Number868.5120
Classification Product Code
BSO  
Subsequent Product Code
MIA  
Date Received03/10/2020
Decision Date 04/27/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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