The following data is part of a premarket notification filed by Global Endoscopy, Inc. with the FDA for Gynecological Laparoscopes.
| Device ID | K003805 |
| 510k Number | K003805 |
| Device Name: | GYNECOLOGICAL LAPAROSCOPES |
| Classification | Laparoscope, Gynecologic (and Accessories) |
| Applicant | GLOBAL ENDOSCOPY, INC. 914 W. ESTES CT. Schaumburg, IL 60193 -4426 |
| Contact | Nick Mircea |
| Correspondent | Nick Mircea GLOBAL ENDOSCOPY, INC. 914 W. ESTES CT. Schaumburg, IL 60193 -4426 |
| Product Code | HET |
| CFR Regulation Number | 884.1720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-12-08 |
| Decision Date | 2001-07-22 |