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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Tomography, Computed, Emission
510(k) Number K962100
Device Name VOLMETRIC COINCIDENCE DETECTION SYSTEM
Applicant
ELSCINT, INC.
505 MAIN ST.
SUITE 300
HACKENSACK,  NJ  07601
Applicant Contact THOMAS J SPACKMAN
Correspondent
ELSCINT, INC.
505 MAIN ST.
SUITE 300
HACKENSACK,  NJ  07601
Correspondent Contact THOMAS J SPACKMAN
Regulation Number892.1200
Classification Product Code
KPS  
Date Received05/30/1996
Decision Date 01/10/1997
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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