The following data is part of a premarket notification filed by Instrumed International, Inc. with the FDA for Instrumed Laparoscope And Accessories.
| Device ID | K040855 |
| 510k Number | K040855 |
| Device Name: | INSTRUMED LAPAROSCOPE AND ACCESSORIES |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | INSTRUMED INTERNATIONAL, INC. KAISERSTR. 9 Tuningen, B.w., DE 78609 |
| Contact | Haiko Bell |
| Correspondent | Stefan Preiss TUV AMERICA, INC. 1775 OLD HIGHWAY 8 New Brighton, MN 55112 -1891 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2004-04-02 |
| Decision Date | 2004-04-16 |
| Summary: | summary |