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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Needle, Hypodermic, Single Lumen
510(k) Number K200017
Device Name Eclipse DermaFlex Cannula
Applicant
Eclipse Medcorp, LLC
5916 Stone Creek Dr. Suite #120
The Colony,  TX  75056
Applicant Contact John Tepper
Correspondent
Eclipse Medcorp, LLC
5916 Stone Creek Dr. Suite #120
The Colony,  TX  75056
Correspondent Contact Julie Summerville
Regulation Number880.5570
Classification Product Code
FMI  
Date Received01/03/2020
Decision Date 11/05/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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