The following data is part of a premarket notification filed by Isoaid, L.l.c. with the FDA for I-125 Rsln [radioactive Seed And Localization Needle].
| Device ID | K141701 |
| 510k Number | K141701 |
| Device Name: | I-125 RSLN [RADIOACTIVE SEED AND LOCALIZATION NEEDLE] |
| Classification | Source, Brachytherapy, Radionuclide |
| Applicant | ISOAID, L.L.C. 7824 CLARK MOODY BLVD. Port Richey, FL 34668 |
| Contact | Mary Ann Greenawalt |
| Correspondent | Mary Ann Greenawalt ISOAID, L.L.C. 7824 CLARK MOODY BLVD. Port Richey, FL 34668 |
| Product Code | KXK |
| CFR Regulation Number | 892.5730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-06-24 |
| Decision Date | 2014-12-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M936IRLS20SSS0 | K141701 | 000 |
| M936IRLS20 | K141701 | 000 |
| M936IRLS20SS0 | K141701 | 000 |
| M936IRLS20S0 | K141701 | 000 |