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 |