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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name illuminator, fiberoptic, surgical field
510(k) Number K853948
Device Name MINNESOTA SCIENTIFIC, INC. OMNI-BEAM
Applicant
MINNESOTA SCIENTIFIC, INC.
2520 KENNEDY ST. NE
MINNEAPOLIS,  MN  55413
Applicant Contact BRUCE A LEVAHN
Correspondent
MINNESOTA SCIENTIFIC, INC.
2520 KENNEDY ST. NE
MINNEAPOLIS,  MN  55413
Correspondent Contact BRUCE A LEVAHN
Regulation Number878.4580
Classification Product Code
HBI  
Date Received09/24/1985
Decision Date 10/16/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
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