The following data is part of a premarket notification filed by Surgical Devices, A Global Business Unit Covidien with the FDA for Eea Hemorrhoid Stapler & Accessories.
| Device ID | K083781 |
| 510k Number | K083781 |
| Device Name: | EEA HEMORRHOID STAPLER & ACCESSORIES |
| Classification | Staple, Implantable |
| Applicant | SURGICAL DEVICES, A GLOBAL BUSINESS UNIT COVIDIEN 60 Middletown Ave North Haven, CT 06473 |
| Contact | Frank Gianelli |
| Correspondent | Frank Gianelli SURGICAL DEVICES, A GLOBAL BUSINESS UNIT COVIDIEN 60 Middletown Ave 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 | 2008-12-19 |
| Decision Date | 2009-02-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20884521047560 | K083781 | 000 |
| 20884521047515 | K083781 | 000 |