The following data is part of a premarket notification filed by Alpha-omega Services, Inc. with the FDA for 10 Curie Irdium 192, Csn00100-192.
| Device ID | K991571 |
| 510k Number | K991571 |
| Device Name: | 10 CURIE IRDIUM 192, CSN00100-192 |
| Classification | Source, Brachytherapy, Radionuclide |
| Applicant | ALPHA-OMEGA SERVICES, INC. 11874 SOUTH EVELYN CIRCLE Houston, TX 77071 |
| Contact | J. Harvey Knauss |
| Correspondent | J. Harvey Knauss ALPHA-OMEGA SERVICES, INC. 11874 SOUTH EVELYN CIRCLE Houston, TX 77071 |
| Product Code | KXK |
| CFR Regulation Number | 892.5730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-05-05 |
| Decision Date | 2000-02-22 |
| Summary: | summary |