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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name system, x-ray, tomography, computed
510(k) Number K961464
Device Name SELECT/SP
Original Applicant
ELSCINT, INC.
505 main st.
suite 300
hackensack,  NJ  07601
Original Contact thomas j spackman, m.d., f.a.c.r.
Regulation Number892.1750
Classification Product Code
JAK  
Date Received04/17/1996
Decision Date 07/03/1996
Decision substantially equivalent (SE)
Classification Advisory Committee Radiology
Review Advisory Committee Radiology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
Recalls CDRH Recalls
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