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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, X-Ray, Mobile
510(k) Number K782155
Device Name GENERAL EQUIPMENT COVER
Applicant
Contour Fabricators, Inc.
14241 Fenton Rd.
Fenton,  MI  48430
Correspondent
Contour Fabricators, Inc.
14241 Fenton Rd.
Fenton,  MI  48430
Regulation Number892.1720
Classification Product Code
IZL  
Date Received12/22/1978
Decision Date 01/17/1979
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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