The following data is part of a premarket notification filed by Endomedix with the FDA for Laparoscopic Introducer.
| Device ID | K922082 |
| 510k Number | K922082 |
| Device Name: | LAPAROSCOPIC INTRODUCER |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | ENDOMEDIX 2162 MICHELSON DR. Irvine, CA 92715 -1304 |
| Contact | Wayne R Hohman |
| Correspondent | Wayne R Hohman ENDOMEDIX 2162 MICHELSON DR. Irvine, CA 92715 -1304 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-05-04 |
| Decision Date | 1992-08-03 |