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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, X-Ray, Stationary
510(k) Number K974597
Device Name ADC COMPACT (AGFA DIAGNOSTIC CENTER)
Applicant
Bayer Corp., Agfa Div.
100 Challenger Rd.
Ridgefield Park,  NJ  07660
Applicant Contact MICHAEL SULLIVAN
Correspondent
Bayer Corp., Agfa Div.
100 Challenger Rd.
Ridgefield Park,  NJ  07660
Correspondent Contact MICHAEL SULLIVAN
Regulation Number892.1680
Classification Product Code
KPR  
Date Received12/09/1997
Decision Date 03/09/1998
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
Recalls CDRH Recalls
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