Accurett
Unit, Cryosurgical, Accessories
H&O EQUIPMENTS, NV/SA
The following data is part of a premarket notification filed by H&o Equipments, Nv/sa with the FDA for Accurett.
Pre-market Notification Details
| Device ID | K161615 |
| 510k Number | K161615 |
| Device Name: | Accurett |
| Classification | Unit, Cryosurgical, Accessories |
| Applicant | H&O EQUIPMENTS, NV/SA RUE DES JOURNALIERS 1 Ghislenghien, BE 7822 |
| Contact | Aline Franck |
| Correspondent | Patsy J. Trisler QSERVE GROUP US, INC. 5600 WISCONSIN AVENUE #509 Chevy Chase, MD 20815 |
| Product Code | GEH |
| CFR Regulation Number | 878.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-06-10 |
| Decision Date | 2016-08-23 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B386SCO216GCARTON2 | K161615 | 000 |
| B386SACT80 | K161615 | 000 |
| B386SACT100 | K161615 | 000 |
| 25407008486109 | K161615 | 000 |
| 25407008486000 | K161615 | 000 |
Trademark Results [Accurett]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ACCURETT 79162075 not registered Dead/Abandoned |
H&O EQUIPMENTS N.V./S.A. 2014-08-27 |
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