The following data is part of a premarket notification filed by Dr. Mach Gmbh & Co. Kg with the FDA for Mach Led Mc.
| Device ID | K093010 |
| 510k Number | K093010 |
| Device Name: | MACH LED MC |
| Classification | Light, Surgical, Ceiling Mounted |
| Applicant | DR. MACH GMBH & CO. KG FLOSSMANNSTRABE 28 Ebersberg, DE 85560 |
| Contact | Rainer Adams |
| Correspondent | Rainer Adams DR. MACH GMBH & CO. KG FLOSSMANNSTRABE 28 Ebersberg, DE 85560 |
| Product Code | FSY |
| CFR Regulation Number | 878.4580 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-09-29 |
| Decision Date | 2010-04-01 |
| Summary: | summary |