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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 K904909
Device Name I/A VITROPHAGE MODEL YPR 2001
Applicant
VISION CARE DEVICES, INC.
1246 REDWOOD BLVD.
REDDING,  CA  96003
Applicant Contact CHET CRACCHIOLO
Correspondent
VISION CARE DEVICES, INC.
1246 REDWOOD BLVD.
REDDING,  CA  96003
Correspondent Contact CHET CRACCHIOLO
Regulation Number886.4150
Classification Product Code
HQE  
Date Received10/31/1990
Decision Date 01/28/1991
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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