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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Imaging, Pulsed Echo, Ultrasonic
510(k) Number K090773
Device Name CFI ULTRASOUND PROBE DRAPE
Applicant
Contour Fabricators, Inc.
14241 Fenton Rd.
Fenton,  MI  48430
Applicant Contact JOHN W SCHAEFER
Correspondent
Contour Fabricators, Inc.
14241 Fenton Rd.
Fenton,  MI  48430
Correspondent Contact JOHN W SCHAEFER
Regulation Number892.1560
Classification Product Code
IYO  
Date Received03/23/2009
Decision Date 09/18/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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