The following data is part of a premarket notification filed by Mint Medical Gmbh with the FDA for Mint Lesion.
| Device ID | K142647 |
| 510k Number | K142647 |
| Device Name: | Mint Lesion |
| Classification | System, Image Processing, Radiological |
| Applicant | MINT MEDICAL GMBH Friedrich-Elbert-Str.2 Dossenheim, DE 69221 |
| Contact | Jochen Neuhaus |
| Correspondent | Matthew Steven Mint Medical Inc. 135 Montgomery St, Suite 18J Jersey City, NJ 07302 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-09-17 |
| Decision Date | 2015-04-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04260495880341 | K142647 | 000 |
| 14260495880331 | K142647 | 000 |
| 04260495880358 | K142647 | 000 |
| 04260495880372 | K142647 | 000 |
| 04260495880389 | K142647 | 000 |
| 04260495880396 | K142647 | 000 |
| 04260495883106 | K142647 | 000 |
| 04260495883113 | K142647 | 000 |