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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Template
510(k) Number K974406
Device Name ORTHOPLAN
Applicant
Ortho-Graphics, Inc.
100 N. Medical Dr. # 4550
Saltlake,  UT  84113
Applicant Contact PETER M STEVENS
Correspondent
Ortho-Graphics, Inc.
100 N. Medical Dr. # 4550
Saltlake,  UT  84113
Correspondent Contact PETER M STEVENS
Regulation Number888.4800
Classification Product Code
HWT  
Date Received11/21/1997
Decision Date 02/18/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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