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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 K950287
Device Name UNIVIT PROBE
Applicant
MEDICAL INSTRUMENT DEVELOPMENT LABORATORIES, INC.
14477 CATALINA ST.
SAN LEANDRO,  CA  94577
Applicant Contact CARL C WANG
Correspondent
MEDICAL INSTRUMENT DEVELOPMENT LABORATORIES, INC.
14477 CATALINA ST.
SAN LEANDRO,  CA  94577
Correspondent Contact CARL C WANG
Regulation Number886.4150
Classification Product Code
HKP  
Date Received01/24/1995
Decision Date 04/10/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
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