The following data is part of a premarket notification filed by Medical Devices, Inc. with the FDA for Meditron Electronic Laparoscopic Insufflator.
| Device ID | K915694 |
| 510k Number | K915694 |
| Device Name: | MEDITRON ELECTRONIC LAPAROSCOPIC INSUFFLATOR |
| Classification | Insufflator, Laparoscopic |
| Applicant | MEDICAL DEVICES, INC. 83 HOBART ST. Hackensack, NJ 07601 |
| Contact | Samuel Dickstein |
| Correspondent | Samuel Dickstein MEDICAL DEVICES, INC. 83 HOBART ST. Hackensack, NJ 07601 |
| Product Code | HIF |
| CFR Regulation Number | 884.1730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-12-23 |
| Decision Date | 1992-06-18 |