The following data is part of a premarket notification filed by Medscope Corp. with the FDA for Medscope 8mm And 10mm Laparoscope.
| Device ID | K903663 |
| 510k Number | K903663 |
| Device Name: | MEDSCOPE 8MM AND 10MM LAPAROSCOPE |
| Classification | Laparoscope, Gynecologic (and Accessories) |
| Applicant | MEDSCOPE CORP. 495 LINDBERG LN. Northbrook, IL 60062 |
| Contact | Joachim Souess |
| Correspondent | Joachim Souess MEDSCOPE CORP. 495 LINDBERG LN. 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 | 1990-08-14 |
| Decision Date | 1992-02-11 |