The following data is part of a premarket notification filed by Kli with the FDA for Insuffalator Laparaoscopic.
| Device ID | K781913 |
| 510k Number | K781913 |
| Device Name: | INSUFFALATOR LAPARAOSCOPIC |
| Classification | Insufflator, Laparoscopic |
| Applicant | KLI 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | HIF |
| CFR Regulation Number | 884.1730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-11-14 |
| Decision Date | 1978-12-04 |