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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Fixation Accessory
510(k) Number K883576
Device Name HORIZON ORTHOPEDIC PIN PROTECTOR
Applicant
Horizon Medical, Inc.
324 State St.
St. Paul,  MN  55107
Applicant Contact KENNETH R BLAKE
Correspondent
Horizon Medical, Inc.
324 State St.
St. Paul,  MN  55107
Correspondent Contact KENNETH R BLAKE
Regulation Number888.3030
Classification Product Code
LYT  
Date Received08/22/1988
Decision Date 09/30/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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