The following data is part of a premarket notification filed by Suturtek Incorporated with the FDA for Suturtek 360 Degree Sternal Closure Device.
| Device ID | K082828 |
| 510k Number | K082828 |
| Device Name: | SUTURTEK 360 DEGREE STERNAL CLOSURE DEVICE |
| Classification | Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile |
| Applicant | SUTURTEK INCORPORATED 6 BROOKSIDE CIRCLE Acton, MA 01720 |
| Contact | Art Rankis |
| Correspondent | Art Rankis SUTURTEK INCORPORATED 6 BROOKSIDE CIRCLE Acton, MA 01720 |
| Product Code | GAQ |
| CFR Regulation Number | 878.4495 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-09-25 |
| Decision Date | 2008-10-14 |
| Summary: | summary |