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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instrument, Vitreous Aspiration And Cutting, Battery-Powered
510(k) Number K761353
Device Name VITEROUS SUCTION CUTTER
Applicant
Concept, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Concept, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number886.4150
Classification Product Code
HKP  
Date Received12/28/1976
Decision Date 01/05/1977
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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