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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Component, Cast
510(k) Number K843780
Device Name VENT-A-CAST
Applicant
Orthopedic Technology, Inc.
10101 S. State St.
Sandy,  UT  84070
Applicant Contact RANDALL M CHRISTENS
Correspondent
Orthopedic Technology, Inc.
10101 S. State St.
Sandy,  UT  84070
Correspondent Contact RANDALL M CHRISTENS
Regulation Number888.5940
Classification Product Code
LGF  
Date Received09/26/1984
Decision Date 11/14/1984
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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