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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 K953046
Device Name PERI-PUSHER
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 Received06/30/1995
Decision Date 09/22/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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