The following data is part of a premarket notification filed by Surgimatix, Inc. with the FDA for Proxifast Absorbable Staple.
| Device ID | K132669 |
| 510k Number | K132669 |
| Device Name: | PROXIFAST ABSORBABLE STAPLE |
| Classification | Staple, Implantable |
| Applicant | SURGIMATIX, INC. 1539 JARVIS AVE Elk Grove Village, IL 60007 |
| Contact | Grace Carlson, Md |
| Correspondent | Grace Carlson, Md SURGIMATIX, INC. 1539 JARVIS AVE Elk Grove Village, IL 60007 |
| Product Code | GDW |
| CFR Regulation Number | 878.4750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-08-27 |
| Decision Date | 2014-01-13 |
| Summary: | summary |