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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Controller, Infusion, Intravascular, Electronic
510(k) Number K894111
Device Name VARI-SET
Applicant
Sonex Medical
2511 S. W. Temple
Salt Lake City,  UT  84115
Applicant Contact REED WINTERTON
Correspondent
Sonex Medical
2511 S. W. Temple
Salt Lake City,  UT  84115
Correspondent Contact REED WINTERTON
Regulation Number880.5725
Classification Product Code
LDR  
Date Received06/12/1989
Decision Date 09/28/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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