The following data is part of a premarket notification filed by Elmed Incorporated with the FDA for Elmed Laparoscopic Instruments And Accessories.
| Device ID | K181173 |
| 510k Number | K181173 |
| Device Name: | ELMED Laparoscopic Instruments And Accessories |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | ELMED Incorporated 35 N Brandon Drive Glendale Heights, IL 60139 |
| Contact | Werner Hausner |
| Correspondent | Werner Hausner ELMED Incorporated 35 N Brandon Drive Glendale Heights, IL 60139 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-05-02 |
| Decision Date | 2019-03-22 |