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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name External Mandibular Fixator And/Or Distractor
510(k) Number K220050
Device Name KLS Martin IPS Distraction
Applicant
KLS Martin L.P.
11201 Saint Johns Industrial Parkway S
Jacksonville,  FL  32246
Applicant Contact Jennifer Damato
Correspondent
KLS Martin L.P.
11201 Saint Johns Industrial Parkway S
Jacksonville,  FL  32246
Correspondent Contact Susan Leander
Regulation Number872.4760
Classification Product Code
MQN  
Date Received01/06/2022
Decision Date 08/11/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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