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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Syringe, Antistick
510(k) Number K980069
Device Name VANISHPOINT SYRINGE
Applicant
Retractable Technologies, Inc.
511 Lobo Ln.
Little Elm,  TX  75068 -0009
Applicant Contact TERANCE GRISSO
Correspondent
Retractable Technologies, Inc.
511 Lobo Ln.
Little Elm,  TX  75068 -0009
Correspondent Contact TERANCE GRISSO
Regulation Number880.5860
Classification Product Code
MEG  
Date Received01/08/1998
Decision Date 02/12/1998
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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