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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Needle, Spinal, Short Term
510(k) Number K172800
Device Name Portex® Lancet Point Spinal Needles with NRFit™ connectors, Portex® Pencil Point Spinal Needles with NRFit™ connectors
Applicant
Smiths Medical Asd, Inc.
6000 Nathan Ln. N
Plymouth,  MN  55442
Applicant Contact Michael R. Johnson
Correspondent
Smiths Medical Asd, Inc.
6000 Nathan Ln. N
Plymouth,  MN  55442
Correspondent Contact Sunita Teekasingh
Regulation Number868.5150
Classification Product Code
MIA  
Date Received09/18/2017
Decision Date 06/14/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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