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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 (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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