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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 K992943
Device Name VIT ENHANCER
Applicant
Medical Instrument Development Laboratories, Inc.
14477 Catalina St.
San Leandro,  CA  94577
Applicant Contact LINDA M UPTON
Correspondent
Medical Instrument Development Laboratories, Inc.
14477 Catalina St.
San Leandro,  CA  94577
Correspondent Contact LINDA M UPTON
Regulation Number886.4150
Classification Product Code
HQE  
Date Received08/31/1999
Decision Date 12/10/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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