The following data is part of a premarket notification filed by Davol Inc., Sub. C.r. Bard, Inc. with the FDA for Salute Ii Disposable Fixation Device, Models 0113070, 0113072, 0113073, 0113077, 0113079.
| Device ID | K051848 |
| 510k Number | K051848 |
| Device Name: | SALUTE II DISPOSABLE FIXATION DEVICE, MODELS 0113070, 0113072, 0113073, 0113077, 0113079 |
| Classification | Staple, Implantable |
| Applicant | DAVOL INC., SUB. C.R. BARD, INC. 100 SOCKANOSSETT CROSSROAD Cranston, RI 02920 |
| Contact | Lucinda L Fox |
| Correspondent | Lucinda L Fox DAVOL INC., SUB. C.R. BARD, INC. 100 SOCKANOSSETT CROSSROAD Cranston, RI 02920 |
| Product Code | GDW |
| CFR Regulation Number | 878.4750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-07-07 |
| Decision Date | 2005-08-11 |
| Summary: | summary |