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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 K193074
Device Name Bevel Up Holder
Applicant
NSP Tech Pte Ltd
10 Admiralty Street, Northlink Building, #02-06
Singapore,  SG 757695
Applicant Contact HC TAN
Correspondent
NSP Tech Pte Ltd
10 Admiralty Street, Northlink Building, #02-06
Singapore,  SG 757695
Correspondent Contact HC TAN
Regulation Number862.1675
Classification Product Code
JKA  
Date Received11/04/2019
Decision Date 04/21/2020
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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