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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Non-Stainless Steel Needle
510(k) Number K163437
Device Name hypodermic Pinpoint™ GT Needle
Applicant
C.R. Bard, Inc.
605 N. 5600 W.
Salt Lake Ciy,,  UT  84116
Applicant Contact Jamie Howell
Correspondent
C.R. Bard, Inc.
605 N. 5600 W.
Salt Lake Ciy,,  UT  84116
Correspondent Contact Jamie Howell
Regulation Number880.5570
Classification Product Code
PVZ  
Date Received12/07/2016
Decision Date 06/23/2017
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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