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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Protector, Wound, Plastic
510(k) Number K911407
Device Name HARDING STERNAL SHIELD
Applicant
Harding Medical Devices
P.O. Box 10151
Greensboro,  NC  27404
Applicant Contact BRIDGET HARDING
Correspondent
Harding Medical Devices
P.O. Box 10151
Greensboro,  NC  27404
Correspondent Contact BRIDGET HARDING
Regulation Number878.4014
Classification Product Code
EYF  
Date Received03/29/1991
Decision Date 07/05/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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