READI-STRAND; MODEL PSSTRAND

Source, Brachytherapy, Radionuclide

WORLDWIDE MEDICAL TECHNOLOGIES, LLC

The following data is part of a premarket notification filed by Worldwide Medical Technologies, Llc with the FDA for Readi-strand; Model Psstrand.

Pre-market Notification Details

Device IDK020337
510k NumberK020337
Device Name:READI-STRAND; MODEL PSSTRAND
ClassificationSource, Brachytherapy, Radionuclide
Applicant WORLDWIDE MEDICAL TECHNOLOGIES, LLC 426 MAIN ST. NORTH P.O. BOX 505 Woodbury,  CT  06798 -0505
ContactGary Lamoureux
CorrespondentGary Lamoureux
WORLDWIDE MEDICAL TECHNOLOGIES, LLC 426 MAIN ST. NORTH P.O. BOX 505 Woodbury,  CT  06798 -0505
Product CodeKXK  
CFR Regulation Number892.5730 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-02-01
Decision Date2002-07-29

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