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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
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