The following data is part of a premarket notification filed by Northgate Technologies, Inc. with the FDA for Modification Model 7201 Insufflator.
| Device ID | K915051 |
| 510k Number | K915051 |
| Device Name: | MODIFICATION MODEL 7201 INSUFFLATOR |
| Classification | Insufflator, Laparoscopic |
| Applicant | NORTHGATE TECHNOLOGIES, INC. 3930 VENTURA DR. Arlington Heights, IL 60004 |
| Contact | Peter A Manzie |
| Correspondent | Peter A Manzie NORTHGATE TECHNOLOGIES, INC. 3930 VENTURA DR. Arlington Heights, IL 60004 |
| Product Code | HIF |
| CFR Regulation Number | 884.1730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-09-27 |
| Decision Date | 1992-06-04 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00885554008333 | K915051 | 000 |