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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name tubes, vials, systems, serum separators, blood collection
510(k) Number K213690
Device Name Eclipse Blood Collection Set
Applicant
Eclipse Medcorp LLC
5916 Stone Creek Drive Suite #120
The Colony,  TX  75056
Applicant Contact Julie Summerville
Correspondent
Eclipse Medcorp LLC
5916 Stone Creek Drive Suite #120
The Colony,  TX  75056
Correspondent Contact Julie Summerville
Regulation Number862.1675
Classification Product Code
JKA  
Date Received11/23/2021
Decision Date 10/26/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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