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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 K072059
Device Name GRIPPER MICRO NEEDLE
Applicant
SMITHS MEDICAL MD, INC.
1265 GREY FOX RD.
ARDEN HILLS,  MN  55112
Applicant Contact BRIAN L HAUGSTAD
Correspondent
SMITHS MEDICAL MD, INC.
1265 GREY FOX RD.
ARDEN HILLS,  MN  55112
Correspondent Contact BRIAN L HAUGSTAD
Regulation Number880.5570
Classification Product Code
FMI  
Subsequent Product Code
FPA  
Date Received07/26/2007
Decision Date 11/01/2007
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
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