The following data is part of a premarket notification filed by Deroyal Industries, Inc. with the FDA for Deroyal Disposable Insufflation Tubing Filter.
| Device ID | K945789 |
| 510k Number | K945789 |
| Device Name: | DEROYAL DISPOSABLE INSUFFLATION TUBING FILTER |
| Classification | Insufflator, Laparoscopic |
| Applicant | DEROYAL INDUSTRIES, INC. 200 DEBUSK LN. Powell, TN 37849 |
| Contact | Debra F Manning |
| Correspondent | Debra F Manning DEROYAL INDUSTRIES, INC. 200 DEBUSK LN. Powell, TN 37849 |
| Product Code | HIF |
| CFR Regulation Number | 884.1730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-11-25 |
| Decision Date | 1995-02-07 |