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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 K153168
Device Name Bi-Blade Vitrectomy Cutter
Applicant
MEDICAL INSTRUMENT DEVELOPMENT LABORATORIES
557 MCCORMICK STREET
SAN LEANDRO,  CA  94577
Applicant Contact Brenda Balletto
Correspondent
MEDICAL INSTRUMENT DEVELOPMENT LABORATORIES
557 MCCORMICK STREET
SAN LEANDRO,  CA  94577
Correspondent Contact Brenda Balletto
Regulation Number886.4150
Classification Product Code
HQE  
Date Received11/02/2015
Decision Date 04/29/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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