The following data is part of a premarket notification filed by Endo Technic Corp. with the FDA for Laparoscopic Instruments.
Device ID | K925114 |
510k Number | K925114 |
Device Name: | LAPAROSCOPIC INSTRUMENTS |
Classification | Coagulator, Culdoscopic (and Accessories) |
Applicant | ENDO TECHNIC CORP. 3027 COMMERICAL AVE. Northbrook, IL 60062 |
Contact | Dam Gudeman |
Correspondent | Dam Gudeman ENDO TECHNIC CORP. 3027 COMMERICAL AVE. Northbrook, IL 60062 |
Product Code | HFI |
CFR Regulation Number | 884.4160 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-10-09 |
Decision Date | 1994-02-28 |