The following data is part of a premarket notification filed by Dr. Mach Gmbh & Co. Kg with the FDA for Mach Led 2sc.
Device ID | K140460 |
510k Number | K140460 |
Device Name: | MACH LED 2SC |
Classification | Light, Surgical, Ceiling Mounted |
Applicant | DR. MACH GMBH & CO. KG FEHMARNSTRASSE 31 Norderstedt, Schleswig-holstein, DE 22846 |
Contact | Gudrun Busch, Ph.d. |
Correspondent | Gudrun Busch, Ph.d. DR. MACH GMBH & CO. KG FEHMARNSTRASSE 31 Norderstedt, Schleswig-holstein, DE 22846 |
Product Code | FSY |
CFR Regulation Number | 878.4580 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2014-02-24 |
Decision Date | 2014-04-03 |
Summary: | summary |