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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 K950359
Device Name KONICA LASER IMAGER LI-21
Applicant
Storch Amini & Munves PC
The Chrysler Bldg.
405 Lexington Ave.
New York,  NY  10174
Applicant Contact RUSSELL D MUNVES
Correspondent
Storch Amini & Munves PC
The Chrysler Bldg.
405 Lexington Ave.
New York,  NY  10174
Correspondent Contact RUSSELL D MUNVES
Regulation Number892.2040
Classification Product Code
LMC  
Date Received01/27/1995
Decision Date 09/06/1995
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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