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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 K800320
Device Name CESIUM-137 AFTERLOADING SYSTEM /GYN.BRA.
Applicant
Amersham Corp.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Amersham Corp.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number892.5650
Classification Product Code
IWJ  
Date Received02/12/1980
Decision Date 03/25/1980
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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