K-number	K203282
Device name	TECHFIT Patient-Specific Maxillofacial System
Applicant	Industrias Medicas Sampedro S.A.S
Product code	JEY
Device class	Class II
Decision date	May 19, 2021
Decision	Substantially Equivalent
Regulation	872.4760

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View the full FDA submission: accessdata.fda.gov

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TECHFIT Patient-Specific Maxillofacial System

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