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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Accelerator, Linear, Medical
510(k) Number K050888
Device Name INTEGRA IMMOBILIZATION SYSTEM
Applicant
Diacor, Inc.
3191 S. 3300 E.,
Suite 100-A
Salt Lake City,  UT  84109
Applicant Contact GLENN N WATERMAN
Correspondent
Diacor, Inc.
3191 S. 3300 E.,
Suite 100-A
Salt Lake City,  UT  84109
Correspondent Contact GLENN N WATERMAN
Regulation Number892.5050
Classification Product Code
IYE  
Date Received04/07/2005
Decision Date 05/23/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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