The following data is part of a premarket notification filed by Covidien with the FDA for Signia Small Diameter Reloads.
| Device ID | K191070 |
| 510k Number | K191070 |
| Device Name: | Signia Small Diameter Reloads |
| Classification | Staple, Implantable |
| Applicant | Covidien 60 Middletown Avenue North Haven, CT 06473 |
| Contact | Frank Gianelli |
| Correspondent | Frank Gianelli Covidien 60 Middletown Avenue North Haven, CT 06473 |
| Product Code | GDW |
| CFR Regulation Number | 878.4750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-04-22 |
| Decision Date | 2019-09-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20884521741888 | K191070 | 000 |
| 20884521741871 | K191070 | 000 |
| 20884521741840 | K191070 | 000 |