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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 K843391
Device Name INFUSION ASPIRATION VITRECTOMY SYS
Applicant
Medical Instrument Development Laboratories, Inc.
P.O. Box 1737
San Leandro,  CA  94577
Applicant Contact WANG
Correspondent
Medical Instrument Development Laboratories, Inc.
P.O. Box 1737
San Leandro,  CA  94577
Correspondent Contact WANG
Regulation Number886.4150
Classification Product Code
HQE  
Date Received08/29/1984
Decision Date 12/19/1984
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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