The following data is part of a premarket notification filed by Srmc Co., Ltd with the FDA for Midi-srs.
| Device ID | K141046 |
| 510k Number | K141046 |
| Device Name: | MIDI-SRS |
| Classification | Powered Laser Surgical Instrument With Microbeam\fractional Output |
| Applicant | SRMC CO., LTD 2651 E CHAPMAN AVE. SUITE 110 Fullerton, CA 92831 |
| Contact | Priscilla Chung |
| Correspondent | Priscilla Chung SRMC CO., LTD 2651 E CHAPMAN AVE. SUITE 110 Fullerton, CA 92831 |
| Product Code | ONG |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-04-23 |
| Decision Date | 2014-12-24 |
| Summary: | summary |