The following data is part of a premarket notification filed by Medigroup with the FDA for Pc-205 Tenckhoff Catheter Rod Obturator.
| Device ID | K823296 |
| 510k Number | K823296 |
| Device Name: | PC-205 TENCKHOFF CATHETER ROD OBTURATOR |
| Classification | System, Peritoneal, Automatic Delivery |
| Applicant | MEDIGROUP 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FKX |
| CFR Regulation Number | 876.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-11-05 |
| Decision Date | 1983-01-26 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884450277478 | K823296 | 000 |
| 10884450277468 | K823296 | 000 |
| 00884450277454 | K823296 | 000 |
| 10884450462789 | K823296 | 000 |