The following data is part of a premarket notification filed by Suturtek Incorporated with the FDA for Suturtek Fastclose Sternum Closure Device.
| Device ID | K032468 |
| 510k Number | K032468 |
| Device Name: | SUTURTEK FASTCLOSE STERNUM CLOSURE DEVICE |
| Classification | Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile |
| Applicant | SUTURTEK INCORPORATED 7 TIFFANY TRAIL Hopkinton, MA 01748 |
| Contact | Debbie Iampietro |
| Correspondent | Debbie Iampietro SUTURTEK INCORPORATED 7 TIFFANY TRAIL Hopkinton, MA 01748 |
| Product Code | GAQ |
| CFR Regulation Number | 878.4495 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-08-11 |
| Decision Date | 2003-09-23 |
| Summary: | summary |