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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Processor, Radiographic-Film, Automatic
510(k) Number K022154
Device Name LEVEL 356 X-RAY FILM PROCESSOR, MODELS MD & MD-D
Applicant
FISCHER INDUSTRIES, INC.
2630 KANEVILLE COURT
GENEVA,  IL  60134
Applicant Contact PHIL O'KEEFE
Correspondent
FISCHER INDUSTRIES, INC.
2630 KANEVILLE COURT
GENEVA,  IL  60134
Correspondent Contact PHIL O'KEEFE
Regulation Number892.1900
Classification Product Code
IXW  
Date Received07/02/2002
Decision Date 09/30/2002
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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