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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Shoe, Cast
510(k) Number K781363
Device Name CAST SHOE
Applicant
Cutler Biomedical
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Cutler Biomedical
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number890.3025
Classification Product Code
IPG  
Date Received08/07/1978
Decision Date 08/14/1978
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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