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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 K872919
Device Name OMNI-TRACT CORRAL RETRACTOR
Applicant
Minnesota Scientific, Inc.
3839 Chandler Dr.
Minneapolis,  MN  55421
Applicant Contact BRUCE A LEVAHN
Correspondent
Minnesota Scientific, Inc.
3839 Chandler Dr.
Minneapolis,  MN  55421
Correspondent Contact BRUCE A LEVAHN
Regulation Number878.4800
Classification Product Code
GAD  
Date Received07/27/1987
Decision Date 08/11/1987
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
Predetermined Change
Control Plan Authorized		 No
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