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 |