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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 K913530
Device Name LOOK VISCODISSECTOR
Applicant
Look, Inc.
2020 Lonnie Abbott Ind. Blvd.
Ada,  OK  74820
Applicant Contact GARY AINSWORTH
Correspondent
Look, Inc.
2020 Lonnie Abbott Ind. Blvd.
Ada,  OK  74820
Correspondent Contact GARY AINSWORTH
Regulation Number886.4670
Classification Product Code
HQC  
Date Received08/08/1991
Decision Date 10/21/1991
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
Recalls CDRH Recalls
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