The following data is part of a premarket notification filed by Core Dynamics, Inc. with the FDA for Entree Needle.
| Device ID | K914426 |
| 510k Number | K914426 |
| Device Name: | ENTREE NEEDLE |
| Classification | Pneumoperitoneum Needle |
| 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 | FHO |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-10-02 |
| Decision Date | 1991-11-27 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20653405011917 | K914426 | 000 |
| 20653405011900 | K914426 | 000 |
| 10653405077923 | K914426 | 000 |
| 10653405046042 | K914426 | 000 |
| 10653405046035 | K914426 | 000 |
| 20885403067942 | K914426 | 000 |
| 20885403067935 | K914426 | 000 |