The following data is part of a premarket notification filed by Worldwide Medical Technologies, Llc with the FDA for Readi-strand; Model Psstrand.
Device ID | K020337 |
510k Number | K020337 |
Device Name: | READI-STRAND; MODEL PSSTRAND |
Classification | Source, Brachytherapy, Radionuclide |
Applicant | WORLDWIDE MEDICAL TECHNOLOGIES, LLC 426 MAIN ST. NORTH P.O. BOX 505 Woodbury, CT 06798 -0505 |
Contact | Gary Lamoureux |
Correspondent | Gary Lamoureux WORLDWIDE MEDICAL TECHNOLOGIES, LLC 426 MAIN ST. NORTH P.O. BOX 505 Woodbury, CT 06798 -0505 |
Product Code | KXK |
CFR Regulation Number | 892.5730 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2002-02-01 |
Decision Date | 2002-07-29 |