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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 K961036
Device Name MBI FIBEROPTIC ENDO-ILLUMINATOR
Applicant
M.B. INDUSTRIES, INC.
1707 MADISON AVE.
GRANITE CITY,  IL  62040
Applicant Contact WAYNE C MOSHER
Correspondent
M.B. INDUSTRIES, INC.
1707 MADISON AVE.
GRANITE CITY,  IL  62040
Correspondent Contact WAYNE C MOSHER
Regulation Number876.1500
Classification Product Code
MPA  
Date Received03/14/1996
Decision Date 07/15/1996
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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