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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, Threaded
510(k) Number K192768
Device Name Temporary Fixation Pins
Applicant
EiserTech, LLC
9988 Hibert Street Suite 302
San Diego,  CA  32131
Applicant Contact Lukas Eisermann
Correspondent
MRC-X, LLC
6075 Poplar Ave
Memphis,  TN  38119
Correspondent Contact Dawn Norman
Regulation Number888.3040
Classification Product Code
JDW  
Subsequent Product Code
HTY  
Date Received09/30/2019
Decision Date 12/26/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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