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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Syringe, Piston
510(k) Number K071027
Device Name TRIBOGLIDE LUBRICATED SILICONE-FREE SYRINGE
Applicant
Tribofilm Research, Inc.
625 Hutton St.
Suite 105
Raleigh,  NC  27606
Applicant Contact VINAY SAKHRANI
Correspondent
Tribofilm Research, Inc.
625 Hutton St.
Suite 105
Raleigh,  NC  27606
Correspondent Contact VINAY SAKHRANI
Regulation Number880.5860
Classification Product Code
FMF  
Date Received04/11/2007
Decision Date 07/20/2007
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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