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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name retention device, suture
510(k) Number K792004
Device Name HEWSON LIGAMENT BUTTON
Applicant
RICHARD'S MEDICAL EQUIP., INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
RICHARD'S MEDICAL EQUIP., INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number878.4930
Classification Product Code
KGS  
Date Received10/03/1979
Decision Date 11/05/1979
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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