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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Camera, Multi Format, Radiological
510(k) Number K921906
Device Name HARRIS MODEL 2000
Applicant
Harris Mfg. Co.
P.O. Box 5878
Trenton,  NJ  08638
Applicant Contact LIANNE E FRAZIER
Correspondent
Harris Mfg. Co.
P.O. Box 5878
Trenton,  NJ  08638
Correspondent Contact LIANNE E FRAZIER
Regulation Number892.2040
Classification Product Code
LMC  
Date Received04/21/1992
Decision Date 11/02/1992
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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