The following data is part of a premarket notification filed by Medigroup, Inc. with the FDA for Faller Trocar.
| Device ID | K120130 |
| 510k Number | K120130 |
| Device Name: | FALLER TROCAR |
| Classification | Catheter, Peritoneal, Long-term Indwelling |
| Applicant | MEDIGROUP, INC. 14 A STONEHILL RD. Oswego, IL 60543 |
| Contact | Irene Navis |
| Correspondent | Irene Navis MEDIGROUP, INC. 14 A STONEHILL RD. Oswego, IL 60543 |
| Product Code | FJS |
| CFR Regulation Number | 876.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-01-17 |
| Decision Date | 2012-05-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10884450169992 | K120130 | 000 |