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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 K111979
Device Name RADIOACTIVE SEED LOCALIZATION NEEDLE
Applicant
Biocompatibles, Inc.
115 Hurley Rd. Bldg. 3f
Oxford,  CT  06478
Applicant Contact WAYNE RICHARDSON
Correspondent
Biocompatibles, Inc.
115 Hurley Rd. Bldg. 3f
Oxford,  CT  06478
Correspondent Contact WAYNE RICHARDSON
Regulation Number892.5730
Classification Product Code
KXK  
Date Received07/12/2011
Decision Date 10/18/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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