The following data is part of a premarket notification filed by Ethicon, Inc. with the FDA for Ethicon Securestrap 5mm Absorbable Strap Fixation Device, Model Strap25.
| Device ID | K093845 |
| 510k Number | K093845 |
| Device Name: | ETHICON SECURESTRAP 5MM ABSORBABLE STRAP FIXATION DEVICE, MODEL STRAP25 |
| Classification | Staple, Implantable |
| Applicant | ETHICON, INC. ROUTE 22 WEST Somerville, NJ 08876 -0151 |
| Contact | Joseph Kiceina |
| Correspondent | Joseph Kiceina ETHICON, INC. ROUTE 22 WEST Somerville, NJ 08876 -0151 |
| Product Code | GDW |
| CFR Regulation Number | 878.4750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-12-15 |
| Decision Date | 2010-04-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30705031132973 | K093845 | 000 |
| 30705031132980 | K093845 | 000 |
| 10705031470552 | K093845 | 000 |
| 10705031470576 | K093845 | 000 |