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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
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