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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pin, Fixation, Smooth
510(k) Number K213982
Device Name Pacific Instruments Orthopedic Fixation Pins and Wires / Kirschner / Guide Wires
Applicant
Pacific Instruments
438 Hobron Ln., Suite 204
Honolulu,  HI  96815
Applicant Contact Tracy Sullivan
Correspondent
Novare Medical Consulting, LLC
1765 Dusty Boot Dr.
Lafayette,  CO  80026
Correspondent Contact Jared Walkenhorst
Regulation Number888.3040
Classification Product Code
HTY  
Subsequent Product Code
JDW  
Date Received12/20/2021
Decision Date 02/17/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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