The following data is part of a premarket notification filed by Sourcetech Medical, L.l.c. with the FDA for Seedlinks, Models 70301, 70302, 70303.
| Device ID | K023210 |
| 510k Number | K023210 |
| Device Name: | SEEDLINKS, MODELS 70301, 70302, 70303 |
| Classification | Source, Brachytherapy, Radionuclide |
| Applicant | SOURCETECH MEDICAL, L.L.C. 295 E. LIES RD. Carol Stream, IL 60188 |
| Contact | David T Sieracki |
| Correspondent | David T Sieracki SOURCETECH MEDICAL, L.L.C. 295 E. LIES RD. Carol Stream, IL 60188 |
| Product Code | KXK |
| CFR Regulation Number | 892.5730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-09-26 |
| Decision Date | 2003-03-28 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00801741184130 | K023210 | 000 |
| 10801741078078 | K023210 | 000 |
| 10801741078085 | K023210 | 000 |
| 10801741078092 | K023210 | 000 |
| 10801741078108 | K023210 | 000 |
| 10801741078115 | K023210 | 000 |
| 10801741078139 | K023210 | 000 |
| 10801741078146 | K023210 | 000 |
| 10801741078153 | K023210 | 000 |
| 00801741184123 | K023210 | 000 |
| 10801741078061 | K023210 | 000 |