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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 K813230
Device Name AFTERLOADING GYNECOLOGICAL APPLICATOR
Applicant
Esi
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Esi
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number892.5650
Classification Product Code
IWJ  
Date Received11/10/1981
Decision Date 12/29/1981
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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