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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 K122355
Device Name VANISHPOINT BLOOD COLLECTION SET
Applicant
RETRACTABLE TECHNOLOGIES, INC.
511 Lobo Ln
Little Elm,  TX  75068
Applicant Contact RHONDA WELLS
Correspondent
RETRACTABLE TECHNOLOGIES, INC.
511 Lobo Ln
Little Elm,  TX  75068
Correspondent Contact RHONDA WELLS
Regulation Number862.1675
Classification Product Code
JKA  
Subsequent Product Code
FPA  
Date Received08/03/2012
Decision Date 08/23/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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