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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name chisel (osteotome)
510(k) Number K780135
Device Name CEMENT EXTRACTION INSTRUMENT SET
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 Number878.4820
Classification Product Code
KDG  
Date Received01/24/1978
Decision Date 01/31/1978
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
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