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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 K760578
Device Name BALANCED CAST SOLE
Applicant
Parke-Davis Co.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Parke-Davis Co.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number890.3025
Classification Product Code
IPG  
Date Received09/03/1976
Decision Date 09/27/1976
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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