The following data is part of a premarket notification filed by Endo Technic Corp. with the FDA for Laparoscopic Inst. (scissors,forceps,needleholder).
| Device ID | K925079 |
| 510k Number | K925079 |
| Device Name: | LAPAROSCOPIC INST. (SCISSORS,FORCEPS,NEEDLEHOLDER) |
| Classification | Laparoscope, Gynecologic (and Accessories) |
| Applicant | ENDO TECHNIC CORP. 3027 COMMERICAL AVE. Northbrook, IL 60062 |
| Contact | Dan Gudeman |
| Correspondent | Dan Gudeman ENDO TECHNIC CORP. 3027 COMMERICAL AVE. Northbrook, IL 60062 |
| Product Code | HET |
| CFR Regulation Number | 884.1720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-10-07 |
| Decision Date | 1994-08-24 |