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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Probe, Radiofrequency Lesion
510(k) Number K190256
Device Name Rulo Radiofrequency Lesion Probe
Applicant
Epimed International, Inc.
13958 Diplomat Drive
Farmers Branch,  TX  75234
Applicant Contact Preston H. Frasier
Correspondent
REGULATORY TECHNOLOGY SERVICES, LLC
1000 Westgate Drive,
Suite 510k
Saint Paul,  MN  55114
Correspondent Contact Mark Job
Regulation Number882.4725
Classification Product Code
GXI  
Date Received02/07/2019
Decision Date 03/08/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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