The following data is part of a premarket notification filed by Andronic Devices, Ltd. with the FDA for Insite Model 20 & Model 15 Insufflators.
| Device ID | K934926 |
| 510k Number | K934926 |
| Device Name: | INSITE MODEL 20 & MODEL 15 INSUFFLATORS |
| Classification | Insufflator, Laparoscopic |
| Applicant | ANDRONIC DEVICES, LTD. SUITE 140 13120 VANIER PLACE Richmond, B.c. Canada V6v 2j2, CA V6v 2j2 |
| Contact | Robert Macneil |
| Correspondent | Robert Macneil ANDRONIC DEVICES, LTD. SUITE 140 13120 VANIER PLACE Richmond, B.c. Canada V6v 2j2, CA V6v 2j2 |
| Product Code | HIF |
| CFR Regulation Number | 884.1730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-10-14 |
| Decision Date | 1994-05-26 |