The following data is part of a premarket notification filed by Core Dynamics, Inc. with the FDA for Entree Cannula.
| Device ID | K911813 |
| 510k Number | K911813 |
| Device Name: | ENTREE CANNULA |
| 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 | 1991-04-23 |
| Decision Date | 1991-07-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10653405045670 | K911813 | 000 |
| 30653405044998 | K911813 | 000 |
| 30653405044981 | K911813 | 000 |
| 30653405044974 | K911813 | 000 |
| 10653405044963 | K911813 | 000 |
| 10653405044949 | K911813 | 000 |
| 30653405044851 | K911813 | 000 |
| 10653405044567 | K911813 | 000 |
| 10653405044550 | K911813 | 000 |
| 10653405044543 | K911813 | 000 |
| 10653405044536 | K911813 | 000 |
| 30653405045001 | K911813 | 000 |
| 30653405045018 | K911813 | 000 |
| 30653405045025 | K911813 | 000 |
| 10653405045212 | K911813 | 000 |
| 30653405045117 | K911813 | 000 |
| 30653405045100 | K911813 | 000 |
| 30653405045094 | K911813 | 000 |
| 30653405045087 | K911813 | 000 |
| 30653405045070 | K911813 | 000 |
| 30653405045063 | K911813 | 000 |
| 30653405045056 | K911813 | 000 |
| 30653405045049 | K911813 | 000 |
| 30653405045032 | K911813 | 000 |
| 30653405044509 | K911813 | 000 |