The following data is part of a premarket notification filed by Dufner Instrumente Gmbh with the FDA for Mictec Endoscopes And Accessories.
Device ID | K002877 |
510k Number | K002877 |
Device Name: | MICTEC ENDOSCOPES AND ACCESSORIES |
Classification | Electrosurgical, Cutting & Coagulation & Accessories |
Applicant | DUFNER INSTRUMENTE GMBH AMSTEL 320-I Amsterdam, NL 1017ap |
Contact | Dagmar Maser |
Correspondent | Dagmar Maser DUFNER INSTRUMENTE GMBH AMSTEL 320-I Amsterdam, NL 1017ap |
Product Code | GEI |
Subsequent Product Code | GCJ |
Subsequent Product Code | HET |
CFR Regulation Number | 878.4400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Abbreviated |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2000-09-15 |
Decision Date | 2001-02-05 |