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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Image Processing, Radiological
510(k) Number K862309
Device Name PC-DISPLAY
Applicant
Hi-Tech Medical Systems, Inc.
17155 Newhope St.
Suite G
Fountain Vall,  CA  92708
Applicant Contact WALTER P NACHBAUR
Correspondent
Hi-Tech Medical Systems, Inc.
17155 Newhope St.
Suite G
Fountain Vall,  CA  92708
Correspondent Contact WALTER P NACHBAUR
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received06/17/1986
Decision Date 11/12/1986
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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