The following data is part of a premarket notification filed by Msi Medserv International Deutschland Gmbh with the FDA for Msi Medserv International-rigid Endoscope.
Device ID | K083840 |
510k Number | K083840 |
Device Name: | MSI MEDSERV INTERNATIONAL-RIGID ENDOSCOPE |
Classification | Endoscope, Rigid |
Applicant | MSI MEDSERV INTERNATIONAL DEUTSCHLAND GMBH ESCAD-STR 3 Pfullendorf, DE D-88630 |
Contact | Christine Strobel |
Correspondent | Christine Strobel MSI MEDSERV INTERNATIONAL DEUTSCHLAND GMBH ESCAD-STR 3 Pfullendorf, DE D-88630 |
Product Code | GCM |
CFR Regulation Number | 876.1500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2008-12-24 |
Decision Date | 2009-09-28 |
Summary: | summary |