The following data is part of a premarket notification filed by Core Dynamics, Inc. with the FDA for Core Disposable Trocars.
| Device ID | K901407 |
| 510k Number | K901407 |
| Device Name: | CORE DISPOSABLE TROCARS |
| Classification | Laparoscope, Gynecologic (and Accessories) |
| Applicant | CORE DYNAMICS, INC. P.O. BOX 16351 Jacksonville, FL 32245 |
| Contact | Tim Reis |
| Correspondent | Tim Reis CORE DYNAMICS, INC. P.O. BOX 16351 Jacksonville, FL 32245 |
| Product Code | HET |
| CFR Regulation Number | 884.1720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-03-26 |
| Decision Date | 1990-06-08 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10653405045984 | K901407 | 000 |
| 10653405045762 | K901407 | 000 |