The following data is part of a premarket notification filed by Gme (german Medical Engineering) Gmbh with the FDA for Gme Exsys 308.
| Device ID | K150752 |
| 510k Number | K150752 |
| Device Name: | GME ExSys 308 |
| Classification | Light, Ultraviolet, Dermatological |
| Applicant | GME (GERMAN MEDICAL ENGINEERING) GMBH GRIMMSTRASSE 23 Nuerenberg, Bavaria, DE 90491 |
| Contact | Stefan Schulze |
| Correspondent | Mike Johnson PHILOSOPHER'S RIVER LLC P O BOX 106 Willow Creek, MT 59760 |
| Product Code | FTC |
| CFR Regulation Number | 878.4630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-03-23 |
| Decision Date | 2015-07-31 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B12510000 | K150752 | 000 |