The following data is part of a premarket notification filed by C.r. Bard, Inc. with the FDA for Brachysource Seed Implants With Sourcecap Bioabsorbable Caps.
| Device ID | K140856 |
| 510k Number | K140856 |
| Device Name: | BRACHYSOURCE SEED IMPLANTS WITH SOURCECAP BIOABSORBABLE CAPS |
| Classification | Source, Brachytherapy, Radionuclide |
| Applicant | C.R. BARD, INC. 8195 INDUSTRIAL BLVD. Covington, GA 30014 |
| Contact | Michele Davis |
| Correspondent | Michele Davis C.R. BARD, INC. 8195 INDUSTRIAL BLVD. Covington, GA 30014 |
| Product Code | KXK |
| CFR Regulation Number | 892.5730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-04-03 |
| Decision Date | 2014-05-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00801741098611 | K140856 | 000 |
| 00801741098581 | K140856 | 000 |
| 00801741078286 | K140856 | 000 |
| 00801741078255 | K140856 | 000 |
| 00801741078248 | K140856 | 000 |