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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 K925330
Device Name SYSTEM, TOMOGRAPHIC, NUCLEAR
Applicant
Rjl Associates, LLC
Ronald Luich
13 Enid Ln.
East Lyme,  CT  06333
Applicant Contact & ASSOCIATES
Correspondent
Rjl Associates, LLC
Ronald Luich
13 Enid Ln.
East Lyme,  CT  06333
Correspondent Contact & ASSOCIATES
Regulation Number892.1200
Classification Product Code
KPS  
Date Received10/21/1992
Decision Date 01/28/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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