SurgiCube
Air Filter Portable Apparatus
SURGICUBE INTERNATIONAL B.V.
The following data is part of a premarket notification filed by Surgicube International B.v. with the FDA for Surgicube.
Pre-market Notification Details
| Device ID | K163455 |
| 510k Number | K163455 |
| Device Name: | SurgiCube |
| Classification | Air Filter Portable Apparatus |
| Applicant | SURGICUBE INTERNATIONAL B.V. SEGGELANT-NOORD 4 Vierpolders, NL 3237 Mg |
| Contact | Ger Vijfvinkel |
| Correspondent | Ger Vijfvinkel SURGICUBE INTERNATIONAL B.V. SEGGELANT-NOORD 4 Vierpolders, NL 3237 Mg |
| Product Code | ORC |
| CFR Regulation Number | 878.5070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-12-09 |
| Decision Date | 2017-09-28 |
| Summary: | summary |
Trademark Results [SurgiCube]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SURGICUBE 79196292 5331966 Live/Registered |
SurgiCube International B.V. 2016-03-04 |
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