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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, Ac-Powered
510(k) Number K891601
Device Name POWER OPERATED AND CONTROLLED VITREOUS SCISSORS
Applicant
Mira, Inc.
87 Rumford Ave.
Waltham,  MA  02453
Applicant Contact R O'BRIEN
Correspondent
Mira, Inc.
87 Rumford Ave.
Waltham,  MA  02453
Correspondent Contact R O'BRIEN
Regulation Number886.4150
Classification Product Code
HQE  
Date Received03/20/1989
Decision Date 05/23/1989
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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