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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Unit, Phacofragmentation
510(k) Number K832423
Device Name ENVISION G21 I/A ENPAK
Applicant
Envision, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Envision, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number886.4670
Classification Product Code
HQC  
Date Received07/22/1983
Decision Date 09/12/1983
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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