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 |