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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Source, Brachytherapy, Radionuclide
510(k) Number K013964
Device Name MODIFICATION TO ACCU-SPACE PLAIN GUT ABSORBABLE SEEDING SPACERS
Applicant
Cp Medical
P.O. Box 6724
Portland,  OR  97208
Applicant Contact MARY ANN GREENWALT
Correspondent
Cp Medical
P.O. Box 6724
Portland,  OR  97208
Correspondent Contact MARY ANN GREENWALT
Regulation Number892.5730
Classification Product Code
KXK  
Date Received12/03/2001
Decision Date 01/24/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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