The following data is part of a premarket notification filed by Leisegang Medical, Inc. with the FDA for Leisegang Laparoscopic Irrigation System/access.
| Device ID | K924134 |
| 510k Number | K924134 |
| Device Name: | LEISEGANG LAPAROSCOPIC IRRIGATION SYSTEM/ACCESS |
| Classification | Endoscope, Battery-powered And Accessories |
| Applicant | LEISEGANG MEDICAL, INC. 6401 CONGRESS AVE. Boca Raton, FL 33487 -2883 |
| Contact | Douglas Kwart |
| Correspondent | Douglas Kwart LEISEGANG MEDICAL, INC. 6401 CONGRESS AVE. Boca Raton, FL 33487 -2883 |
| Product Code | GCS |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-08-18 |
| Decision Date | 1993-07-02 |