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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 K981280
Device Name CP 1000, CURIX HT 330, CLASSIC E.O.S., CURIX HT 530, MAMORAY HT 300, MAMORAY CMPACT PLUS, CURIX COMPACT PLUS, CURIX COMS
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 Number892.1900
Classification Product Code
IXW  
Date Received04/08/1998
Decision Date 04/30/1998
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
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