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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Table, Radiographic, Tilting
510(k) Number K905501
Device Name ELITE 5000
Applicant
FISCHER IMAGING CORP.
2301 WINDSOR CT.
ADDISON,  IL  60101
Applicant Contact WILLIAM J ENGEL
Correspondent
FISCHER IMAGING CORP.
2301 WINDSOR CT.
ADDISON,  IL  60101
Correspondent Contact WILLIAM J ENGEL
Regulation Number892.1980
Classification Product Code
IXR  
Date Received12/07/1990
Decision Date 01/18/1991
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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