The following data is part of a premarket notification filed by Imagyn Medical Technologies, Inc. with the FDA for Isostar I-125 Interstitial Seed, Model Is-12501.
| Device ID | K991526 |
| 510k Number | K991526 |
| Device Name: | ISOSTAR I-125 INTERSTITIAL SEED, MODEL IS-12501 |
| Classification | Source, Brachytherapy, Radionuclide |
| Applicant | IMAGYN MEDICAL TECHNOLOGIES, INC. 3050 REDHILL AVE. Costa Mesa, CA 92626 |
| Contact | Cheryl Blake |
| Correspondent | Cheryl Blake IMAGYN MEDICAL TECHNOLOGIES, INC. 3050 REDHILL AVE. Costa Mesa, CA 92626 |
| Product Code | KXK |
| CFR Regulation Number | 892.5730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-05-03 |
| Decision Date | 1999-06-17 |
| Summary: | summary |