The following data is part of a premarket notification filed by Core Dynamics, Inc. with the FDA for Entree Blunt Tip Trocar And Adapter.
| Device ID | K932020 |
| 510k Number | K932020 |
| Device Name: | ENTREE BLUNT TIP TROCAR AND ADAPTER |
| Classification | Laparoscope, Gynecologic (and Accessories) |
| 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 | HET |
| CFR Regulation Number | 884.1720 [🔎] |
| 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 |
|---|---|---|
| 30653405044721 | K932020 | 000 |
| 30653405044714 | K932020 | 000 |
| 30653405044707 | K932020 | 000 |
| 30653405044677 | K932020 | 000 |
| 30653405044660 | K932020 | 000 |
| 30653405044646 | K932020 | 000 |
| 30653405044639 | K932020 | 000 |
| 30653405044608 | K932020 | 000 |