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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 K021311
Device Name SYNTHETIC ABSORBABLE SEEDING SPACERS MADE OF POLYDIOXANONE MATERIAL
Applicant
Cp Medical
836 NE 24th Ave.
Portland,  OR  97232
Applicant Contact MARY ANN GREENAWALT
Correspondent
Cp Medical
836 NE 24th Ave.
Portland,  OR  97232
Correspondent Contact MARY ANN GREENAWALT
Regulation Number892.5730
Classification Product Code
KXK  
Date Received04/25/2002
Decision Date 07/13/2002
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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