DReal
Drills, Burrs, Trephines & Accessories (simple, Powered)
CAREVATURE MEDICAL LTD
The following data is part of a premarket notification filed by Carevature Medical Ltd with the FDA for Dreal.
Pre-market Notification Details
| Device ID | K153519 |
| 510k Number | K153519 |
| Device Name: | DReal |
| Classification | Drills, Burrs, Trephines & Accessories (simple, Powered) |
| Applicant | CAREVATURE MEDICAL LTD 42 Tvuot Haarets St. Tel Aviv, IL 6954648 |
| Contact | Orly Maor |
| Correspondent | Orly Maor CAREVATURE MEDICAL LTD 42 Tvuot Haarets St. Tel Aviv, IL 6954648 |
| Product Code | HBE |
| CFR Regulation Number | 882.4310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-12-08 |
| Decision Date | 2016-03-16 |
| Summary: | summary |
Trademark Results [DReal]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 DREAL 79197495 5352559 Live/Registered |
Carevature Medical Ltd. 2016-10-09 |
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