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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 K062214
Device Name BRACHYSCIENCES STRANDPORT
Applicant
Worldwide Medical Technologies, LLC
115 Hurley Rd. Bldg. 3b
Oxford,  CT  06478
Applicant Contact WAYNE W RICHARDSON
Correspondent
Worldwide Medical Technologies, LLC
115 Hurley Rd. Bldg. 3b
Oxford,  CT  06478
Correspondent Contact WAYNE W RICHARDSON
Regulation Number892.5730
Classification Product Code
KXK  
Date Received08/01/2006
Decision Date 03/01/2007
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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