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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 K973219
Device Name AMBER DU
Applicant
Oldelft Corp. of America
9108 Guilford Rd.
Columbia,  MD  21046
Applicant Contact L. DON PHILLIPS
Correspondent
Oldelft Corp. of America
9108 Guilford Rd.
Columbia,  MD  21046
Correspondent Contact L. DON PHILLIPS
Regulation Number892.1680
Classification Product Code
KPR  
Date Received08/27/1997
Decision Date 10/08/1997
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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