The following data is part of a premarket notification filed by C.r. Bard, Inc. with the FDA for Sourcelink.
Device ID | K041576 |
510k Number | K041576 |
Device Name: | SOURCELINK |
Classification | Source, Brachytherapy, Radionuclide |
Applicant | C.R. BARD, INC. 8195 INDUSTRIAL BLVD. Covington, GA 30014 -2655 |
Contact | John C Knorpp |
Correspondent | John C Knorpp C.R. BARD, INC. 8195 INDUSTRIAL BLVD. Covington, GA 30014 -2655 |
Product Code | KXK |
CFR Regulation Number | 892.5730 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2004-06-11 |
Decision Date | 2004-07-02 |
Summary: | summary |