The following data is part of a premarket notification filed by C.r. Bard Inc. with the FDA for Capsure Fixation System - Straight 5mm X 37 Cm – 30 Permanent Fasteners, Capsure Fixation System - Straight 5mm X 37 Cm – 15 Permanent Fasteners.
| Device ID | K160900 |
| 510k Number | K160900 |
| Device Name: | CapSure Fixation System - Straight 5mm X 37 Cm – 30 Permanent Fasteners, CapSure Fixation System - Straight 5mm X 37 Cm – 15 Permanent Fasteners |
| Classification | Staple, Implantable |
| Applicant | C.R. BARD INC. 100 CROSSINGS BLVD Warwick, RI 02886 |
| Contact | Andrew Harrell |
| Correspondent | Andrew Harrell C.R. BARD INC. 100 CROSSINGS BLVD Warwick, RI 02886 |
| Product Code | GDW |
| CFR Regulation Number | 878.4750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-04-01 |
| Decision Date | 2016-05-31 |
| Summary: | summary |