The following data is part of a premarket notification filed by Axiom Technology Partners, Llc with the FDA for Axiom Fascial Closure System.
| Device ID | K103412 |
| 510k Number | K103412 |
| Device Name: | AXIOM FASCIAL CLOSURE SYSTEM |
| Classification | Endoscopic Tissue Approximation Device |
| Applicant | AXIOM TECHNOLOGY PARTNERS, LLC 2939 ALHAMBRA DRIVE Belmont, CA 94002 |
| Contact | Richard Rush |
| Correspondent | Richard Rush AXIOM TECHNOLOGY PARTNERS, LLC 2939 ALHAMBRA DRIVE Belmont, CA 94002 |
| Product Code | OCW |
| Subsequent Product Code | GCJ |
| Subsequent Product Code | HCF |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-11-22 |
| Decision Date | 2010-12-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 24026704558838 | K103412 | 000 |