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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name retractor
510(k) Number K001339
Device Name MRI FASTSYSTEM RETRACTOR SYSTEM
Applicant
OMNI-TRACT SURGICAL, DIV. MINN. SCIENTIFIC, INC.
1100 NEW BRIGHTON BLVD.
MINNEAPOLIS,  MN  55413 -1660
Applicant Contact CATHERINE MILLER
Correspondent
OMNI-TRACT SURGICAL, DIV. MINN. SCIENTIFIC, INC.
1100 NEW BRIGHTON BLVD.
MINNEAPOLIS,  MN  55413 -1660
Correspondent Contact CATHERINE MILLER
Regulation Number878.4800
Classification Product Code
GAD  
Date Received04/27/2000
Decision Date 05/17/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Special
Reviewed by Third Party No
Combination Product No
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