The following data is part of a premarket notification filed by Isoaid, L.l.c. with the FDA for Isoaid Advantage Pd-103, Model Iapd-103a.
| Device ID | K033770 |
| 510k Number | K033770 |
| Device Name: | ISOAID ADVANTAGE PD-103, MODEL IAPD-103A |
| Classification | Source, Brachytherapy, Radionuclide |
| Applicant | ISOAID, L.L.C. 7824 CLARK MOODY BLVD. Port Richey, FL 34668 |
| Contact | Max Taghizadeh |
| Correspondent | Max Taghizadeh 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 | 2003-12-03 |
| Decision Date | 2004-04-08 |
| Summary: | summary |