The following data is part of a premarket notification filed by Qrc Consulting with the FDA for Suturtek Fastclose Fascia Closure Device.
| Device ID | K011105 |
| 510k Number | K011105 |
| Device Name: | SUTURTEK FASTCLOSE FASCIA CLOSURE DEVICE |
| Classification | Suture, Absorbable, Natural |
| Applicant | QRC CONSULTING 7 TIFFANY TRAIL Hopkinton, MA 01748 |
| Contact | Debbie Iampietro |
| Correspondent | Debbie Iampietro QRC CONSULTING 7 TIFFANY TRAIL Hopkinton, MA 01748 |
| Product Code | GAL |
| Subsequent Product Code | GAB |
| Subsequent Product Code | HCF |
| CFR Regulation Number | 878.4830 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-04-11 |
| Decision Date | 2001-05-30 |