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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Spot-Film
510(k) Number K881589
Device Name 14X14 MULTIFORMAT SPOT FILMER, NO. 6650.400
Applicant
Continental X-Ray Corp.
Post Office Box 5571
Chicago,  IL  60680
Applicant Contact JAMES M TAYLOR
Correspondent
Continental X-Ray Corp.
Post Office Box 5571
Chicago,  IL  60680
Correspondent Contact JAMES M TAYLOR
Regulation Number892.1670
Classification Product Code
IXL  
Date Received04/13/1988
Decision Date 07/18/1988
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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