The following data is part of a premarket notification filed by Northgate Technologies Inc. with the FDA for Nebulae I.
| Device ID | K120151 |
| 510k Number | K120151 |
| Device Name: | NEBULAE I |
| Classification | Insufflator, Laparoscopic |
| Applicant | NORTHGATE TECHNOLOGIES INC. 1591 SCOTTSDALE COURT Elgin, IL 60123 |
| Contact | Casey Kurek |
| Correspondent | Casey Kurek NORTHGATE TECHNOLOGIES INC. 1591 SCOTTSDALE COURT Elgin, IL 60123 |
| Product Code | HIF |
| Subsequent Product Code | FCX |
| Subsequent Product Code | OSX |
| CFR Regulation Number | 884.1730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-01-18 |
| Decision Date | 2012-08-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00885554032352 | K120151 | 000 |
| 00885554032345 | K120151 | 000 |
| 03596010673497 | K120151 | 000 |