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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 K023179
Device Name READI-STRAND, MODEL PSSTRAND
Applicant
Worldwide Medical Technologies, LLC
426 Main St. N.
Woodbury,  CT  06798 -0505
Applicant Contact GARY LAMOUREUX
Correspondent
Worldwide Medical Technologies, LLC
426 Main St. N.
Woodbury,  CT  06798 -0505
Correspondent Contact GARY LAMOUREUX
Regulation Number892.5730
Classification Product Code
KXK  
Date Received09/24/2002
Decision Date 07/02/2003
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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