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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
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