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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Protractor
510(k) Number K822305
Device Name ORTHO-LEVEL
Applicant
Frontier Products
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Frontier Products
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number888.4600
Classification Product Code
HTH  
Date Received07/27/1982
Decision Date 08/20/1982
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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