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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ultrasound, Sinus
510(k) Number K960421
Device Name SINUSCAN 102/SINUSPRINT
Applicant
Ferguson Medical
3407 Bay Ave.
Chico,  CA  95973 -8619
Applicant Contact FRANK FERGUSON
Correspondent
Ferguson Medical
3407 Bay Ave.
Chico,  CA  95973 -8619
Correspondent Contact FRANK FERGUSON
Regulation Number892.1560
Classification Product Code
LWI  
Subsequent Product Code
ITX  
Date Received01/29/1996
Decision Date 04/16/1997
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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