The following data is part of a premarket notification filed by Northgate Technologies Inc. with the FDA for Nebulae Srs Laparoscopic Surgical Smoke Removal System.
| Device ID | K202944 |
| 510k Number | K202944 |
| Device Name: | NEBULAE SRS Laparoscopic Surgical Smoke Removal System |
| Classification | Apparatus, Exhaust, Surgical |
| Applicant | Northgate Technologies Inc. 1591 Scottsdale Court Elgin, IL 60123 |
| Contact | Todd Gatto |
| Correspondent | Todd Gatto Northgate Technologies Inc. 1591 Scottsdale Court Elgin, IL 60123 |
| Product Code | FYD |
| CFR Regulation Number | 878.5070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-09-30 |
| Decision Date | 2021-03-25 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00817183020684 | K202944 | 000 |
| 00817183020660 | K202944 | 000 |