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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Rasp
510(k) Number K760109
Device Name PROSTHESIS, TOTAL HIP-RASP
Applicant
Orthopedic Equipment Co., Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Orthopedic Equipment Co., Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number878.4800
Classification Product Code
HTR  
Date Received06/24/1976
Decision Date 07/20/1976
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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