The following data is part of a premarket notification filed by Dexide, Inc. with the FDA for Dexide Insufflation Tubing With Filter.
| Device ID | K944509 |
| 510k Number | K944509 |
| Device Name: | DEXIDE INSUFFLATION TUBING WITH FILTER |
| Classification | Insufflator, Laparoscopic |
| Applicant | DEXIDE, INC. 7509 FLAGSTONE DR. Fort Worth, TX 76118 |
| Contact | Roger Cooper |
| Correspondent | Roger Cooper DEXIDE, INC. 7509 FLAGSTONE DR. Fort Worth, TX 76118 |
| Product Code | HIF |
| CFR Regulation Number | 884.1730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-09-15 |
| Decision Date | 1995-02-07 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20884521080796 | K944509 | 000 |