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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 K920769
Device Name KONICA LI 10 AND 10A LASER IMAGER
Applicant
Konica Corp.
9 E. 37th St.
New York,  NY  10016
Applicant Contact RUSSELL D MUNVES
Correspondent
Konica Corp.
9 E. 37th St.
New York,  NY  10016
Correspondent Contact RUSSELL D MUNVES
Regulation Number892.2040
Classification Product Code
LMC  
Date Received02/06/1992
Decision Date 05/06/1992
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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