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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tube Mount, X-Ray, Diagnostic
510(k) Number K900234
Device Name PFM-90 CEILING TUBE SUPPORT
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 Number892.1770
Classification Product Code
IYB  
Date Received01/17/1990
Decision Date 02/26/1990
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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