The following data is part of a premarket notification filed by Core Dynamics, Inc. with the FDA for Entree Cannula Fascia Anchors.
| Device ID | K932021 |
| 510k Number | K932021 |
| Device Name: | ENTREE CANNULA FASCIA ANCHORS |
| Classification | Cannula And Trocar, Suprapubic, Non-disposable |
| Applicant | CORE DYNAMICS, INC. 11222-4 ST. JOHNS INDUSTRIAL PARKWAY Jacksonville, FL 32246 |
| Contact | Tim Reis |
| Correspondent | Tim Reis CORE DYNAMICS, INC. 11222-4 ST. JOHNS INDUSTRIAL PARKWAY Jacksonville, FL 32246 |
| Product Code | FBM |
| CFR Regulation Number | 876.5090 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-04-23 |
| Decision Date | 1994-01-11 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30653405045735 | K932021 | 000 |
| 20653405045721 | K932021 | 000 |
| 30653405045704 | K932021 | 000 |