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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, imaging, pulsed echo, ultrasonic
510(k) Number K952551
Device Name JANUS I
Applicant
3D ULTRASOUND, INC.
302 EAST PETTIGREW ST.
SUITE 307
DURHAM,  NC  27701
Applicant Contact JOHN OXAAL
Correspondent
3D ULTRASOUND, INC.
302 EAST PETTIGREW ST.
SUITE 307
DURHAM,  NC  27701
Correspondent Contact JOHN OXAAL
Regulation Number892.1560
Classification Product Code
IYO  
Date Received06/02/1995
Decision Date 12/11/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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