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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name endoilluminator
510(k) Number K964553
Device Name MBI CO-AXIAL ILLUMINATED RETINAL PICK
Applicant
M.B. INDUSTRIES, INC.
1707 MADISON AVE.
GRANITE CITY,  IL  62040
Applicant Contact WILLIAM BUTTERMORE
Correspondent
M.B. INDUSTRIES, INC.
1707 MADISON AVE.
GRANITE CITY,  IL  62040
Correspondent Contact WILLIAM BUTTERMORE
Regulation Number876.1500
Classification Product Code
MPA  
Date Received11/13/1996
Decision Date 05/13/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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