The following data is part of a premarket notification filed by Northgate Technologies, Inc. with the FDA for 40lpm Abdominal Insufflator, Catalog # 72-00203-0.
| Device ID | K022052 |
| 510k Number | K022052 |
| Device Name: | 40LPM ABDOMINAL INSUFFLATOR, CATALOG # 72-00203-0 |
| Classification | Insufflator, Laparoscopic |
| Applicant | NORTHGATE TECHNOLOGIES, INC. 600 CHURCH RD. Elgin, IL 60123 |
| Contact | Casey Kurek |
| Correspondent | Casey Kurek NORTHGATE TECHNOLOGIES, INC. 600 CHURCH RD. Elgin, IL 60123 |
| Product Code | HIF |
| CFR Regulation Number | 884.1730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-06-24 |
| Decision Date | 2003-01-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00817183020264 | K022052 | 000 |
| 00817183020714 | K022052 | 000 |
| 00817183020646 | K022052 | 000 |
| 00817183020653 | K022052 | 000 |
| 03596010542359 | K022052 | 000 |
| 20845854045357 | K022052 | 000 |
| 20845854045364 | K022052 | 000 |
| 00885554010671 | K022052 | 000 |
| 00885554011203 | K022052 | 000 |
| 00885554011418 | K022052 | 000 |
| 00885554011821 | K022052 | 000 |
| 00885554012286 | K022052 | 000 |
| 00817183020196 | K022052 | 000 |
| 00817183020202 | K022052 | 000 |
| 00817183020257 | K022052 | 000 |
| 10845854045350 | K022052 | 000 |