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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laparoscope, General & Plastic Surgery
510(k) Number K950214
Device Name ABDOMINAL WALL RETRACTOR
Applicant
Omni-Tract Surgical, Div. Minn. Scientific, Inc.
1100 New Brighton Blvd.
Minneapolis,  MN  55413
Applicant Contact STEVE LEVAHN
Correspondent
Omni-Tract Surgical, Div. Minn. Scientific, Inc.
1100 New Brighton Blvd.
Minneapolis,  MN  55413
Correspondent Contact STEVE LEVAHN
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received01/19/1995
Decision Date 02/06/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
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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