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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
Applicant
Elscint, Inc.
505 Main St.
Suite 300
Hackensack,  NJ  07601
Applicant Contact THOMAS J SPACKMAN, M.D., F.A.C.R.
Correspondent
Elscint, Inc.
505 Main St.
Suite 300
Hackensack,  NJ  07601
Correspondent 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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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