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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Drape, Surgical
510(k) Number K970185
Device Name STERILE DISPOSABLE EQUIPMENT MAGNET COVER
Applicant
Contour Fabricators, Inc.
4100 E. Baldwin Ave.
Grand Blanc,  MI  48439
Applicant Contact MICHAEL CZOP
Correspondent
Contour Fabricators, Inc.
4100 E. Baldwin Ave.
Grand Blanc,  MI  48439
Correspondent Contact MICHAEL CZOP
Regulation Number878.4370
Classification Product Code
KKX  
Date Received01/17/1997
Decision Date 04/10/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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