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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 K970900
Device Name INSTRUMENT HOLDER
Applicant
Contour Fabricators, Inc.
4100 E. Baldwin Ave.
P.O. Box 56
Grand Blanc,  MI  48439
Applicant Contact MICHAEL CZOP
Correspondent
Contour Fabricators, Inc.
4100 E. Baldwin Ave.
P.O. Box 56
Grand Blanc,  MI  48439
Correspondent Contact MICHAEL CZOP
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received03/11/1997
Decision Date 05/22/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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