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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plate, Bone
510(k) Number K203282
Device Name TECHFIT Patient-Specific Maxillofacial System
Applicant
Industrias Medicas Sampedro S.A.S
Carrera 47 N 100 Sur 40 Centro Industrial Portal Del Sur
Bodega 14
La Estrella,  CO 055468
Applicant Contact Leidy Johanna Toro Gonzalez
Correspondent
Industrias Medicas Sampedro S.A.S
Carrera 47 N 100 Sur 40 Centro Industrial Portal Del Sur
Bodega 14
La Estrella,  CO 055468
Correspondent Contact Leidy Johanna Toro Gonzalez
Regulation Number872.4760
Classification Product Code
JEY  
Date Received11/06/2020
Decision Date 05/19/2021
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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