The following data is part of a premarket notification filed by Core Dynamics, Inc. with the FDA for Core Disposable Insufflation Tubing.
| Device ID | K901413 |
| 510k Number | K901413 |
| Device Name: | CORE DISPOSABLE INSUFFLATION TUBING |
| Classification | Insufflator, Carbon-dioxide, Uterotubal (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 | HES |
| CFR Regulation Number | 884.1300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-03-26 |
| Decision Date | 1990-09-24 |