MI DeTACH
Clamp, Vascular
Biorep Technologies, Inc
The following data is part of a premarket notification filed by Biorep Technologies, Inc with the FDA for Mi Detach.
Pre-market Notification Details
| Device ID | K210006 |
| 510k Number | K210006 |
| Device Name: | MI DeTACH |
| Classification | Clamp, Vascular |
| Applicant | Biorep Technologies, Inc 15804 NW 57th Avenue Miami Lakes, FL 33014 |
| Contact | Victoria Enjamio |
| Correspondent | Victoria Enjamio Biorep Technologies, Inc 15804 NW 57th Avenue Miami Lakes, FL 33014 |
| Product Code | DXC |
| CFR Regulation Number | 870.4450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-01-04 |
| Decision Date | 2021-03-04 |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00858733006338 | K210006 | 000 |
| 00858733006291 | K210006 | 000 |
| 00858733006284 | K210006 | 000 |
| 00858733006307 | K210006 | 000 |
| 00858733006246 | K210006 | 000 |
Trademark Results [MI DeTACH]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 MI DETACH 86663016 5628163 Live/Registered |
Miami Instruments LLC 2015-06-15 |
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