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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 K071947
Device Name VACU-MED BLOOD COLLECTION NEEDLES
Applicant
Shina Corp.
5353 Wayzata Blvd.
Suite 305
Minneapolis,  MN  55416
Applicant Contact CAROLE STAMP
Correspondent
Shina Corp.
5353 Wayzata Blvd.
Suite 305
Minneapolis,  MN  55416
Correspondent Contact CAROLE STAMP
Regulation Number880.5570
Classification Product Code
FMI  
Date Received07/13/2007
Decision Date 10/12/2007
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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