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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Conformer, Ophthalmic
510(k) Number K970319
Device Name OCULAR CONFORMER
Applicant
Xavier A. Guerra, Ocularist, Inc.
4640 Centerview Dr.
San Antonio,  TX  78228
Applicant Contact XAVIER A GUERRA
Correspondent
Xavier A. Guerra, Ocularist, Inc.
4640 Centerview Dr.
San Antonio,  TX  78228
Correspondent Contact XAVIER A GUERRA
Regulation Number886.3130
Classification Product Code
HQN  
Date Received01/28/1997
Decision Date 07/07/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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