The following data is part of a premarket notification filed by Isoaid, L.l.c. with the FDA for Advantage-strand/ Advantage-load Brachytherapy Kit, Model Iaslbka.
| Device ID | K091117 |
| 510k Number | K091117 |
| Device Name: | ADVANTAGE-STRAND/ ADVANTAGE-LOAD BRACHYTHERAPY KIT, MODEL IASLBKA |
| Classification | Source, Brachytherapy, Radionuclide |
| Applicant | ISOAID, L.L.C. 7824 CLARK MOODY BLVD. Port Richey, FL 34668 |
| Contact | Benjamin Roedell |
| Correspondent | Benjamin Roedell 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 | 2009-04-17 |
| Decision Date | 2009-09-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M936PBKASAL9 | K091117 | 000 |
| M936PBKAS9 | K091117 | 000 |
| M936PBKAL9 | K091117 | 000 |
| M936IBKASAL9 | K091117 | 000 |
| M936IBKAS9 | K091117 | 000 |
| M936IBKAL9 | K091117 | 000 |