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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Needle, Hypodermic, Single Lumen
510(k) Number K080235
Device Name SAFETY INFUSION SET
Applicant
Greiner Bio-One Vacuette North America
13801 Eck Rd.
Hydes,  MD  21082
Applicant Contact JUDITH SMITH
Correspondent
Greiner Bio-One Vacuette North America
13801 Eck Rd.
Hydes,  MD  21082
Correspondent Contact JUDITH SMITH
Regulation Number880.5570
Classification Product Code
FMI  
Date Received01/30/2008
Decision Date 04/24/2008
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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