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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Applicator, Radionuclide, Manual
510(k) Number K893703
Device Name AFTER LOADING DEVICE KIT
Applicant
Medical Radiation Devices, Inc.
P.O. Box 6762
Dothan,  AL  36302
Applicant Contact WILLIAM KAN
Correspondent
Medical Radiation Devices, Inc.
P.O. Box 6762
Dothan,  AL  36302
Correspondent Contact WILLIAM KAN
Regulation Number892.5650
Classification Product Code
IWJ  
Date Received05/18/1989
Decision Date 09/18/1989
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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