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 |