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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cover, Limb
510(k) Number K770223
Device Name HEAVY FOAM HEEL & ELBOW PROTECTORS
Applicant
Robert R. Moore
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Robert R. Moore
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number890.3025
Classification Product Code
IPM  
Date Received02/03/1977
Decision Date 02/23/1977
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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