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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, Fluoroscopic, Image-Intensified
510(k) Number K864749
Device Name TELAMAT
Applicant
Comet Ltd. C/O Radiology Resources, Inc.
4 Draper St.
Worburn,  MA  01801
Applicant Contact CHARLES E MORELAND
Correspondent
Comet Ltd. C/O Radiology Resources, Inc.
4 Draper St.
Worburn,  MA  01801
Correspondent Contact CHARLES E MORELAND
Regulation Number892.1650
Classification Product Code
JAA  
Date Received12/05/1986
Decision Date 02/10/1987
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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