The following data is part of a premarket notification filed by Ethicon, Inc. with the FDA for Ethicon Securestrap Open Absorbable Strap Fixation Device.
| Device ID | K123114 |
| 510k Number | K123114 |
| Device Name: | ETHICON SECURESTRAP OPEN ABSORBABLE STRAP FIXATION DEVICE |
| Classification | Staple, Implantable |
| Applicant | ETHICON, INC. ROUTE 22 WEST P.O. BOX 151 Somerville, NJ 08876 -0151 |
| Contact | Susan Lin |
| Correspondent | Susan Lin ETHICON, INC. ROUTE 22 WEST P.O. BOX 151 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 | 2012-10-03 |
| Decision Date | 2013-02-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30705031202744 | K123114 | 000 |
| 30705031231058 | K123114 | 000 |
| 10705031470569 | K123114 | 000 |