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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 K973422
Device Name LASERSHARE PRINT SPOOLER(2100[SOLARIS X86]/(1500[WINDOWS NT])
Applicant
Dejarnette Research Systems
401 Washington Ave.
Suite 700
Towson,  MD  21204
Applicant Contact ERIC J FINEGAN
Correspondent
Dejarnette Research Systems
401 Washington Ave.
Suite 700
Towson,  MD  21204
Correspondent Contact ERIC J FINEGAN
Regulation Number892.2040
Classification Product Code
LMC  
Date Received09/10/1997
Decision Date 10/28/1997
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
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