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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name set, administration, intravascular
510(k) Number K112512
Device Name VANISHPOINT BLOOD COLLECTION SET
Applicant
RETRACTABLE TECHNOLOGIES, INC.
511 LOBO LN.
LITTLE ELM,  TX  75068 -0009
Applicant Contact RHONDA WELLS
Correspondent
RETRACTABLE TECHNOLOGIES, INC.
511 LOBO LN.
LITTLE ELM,  TX  75068 -0009
Correspondent Contact RHONDA WELLS
Regulation Number880.5440
Classification Product Code
FPA  
Subsequent Product Code
JKA  
Date Received08/30/2011
Decision Date 10/20/2011
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
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