The following data is part of a premarket notification filed by Simex Medizintechnik Gmbh with the FDA for Flosure Ventilation Patch.
| Device ID | K150459 |
| 510k Number | K150459 |
| Device Name: | FloSure Ventilation Patch |
| Classification | Negative Pressure Wound Therapy Powered Suction Pump |
| Applicant | SIMEX MEDIZINTECHNIK GmbH Post Box 1207 Deisslingen, DE D-78649 |
| Contact | Hamid Khosrowshahi |
| Correspondent | Hamid Khosrowshahi FLOSURE TECHNOLOGIES LLC P.O. BOX 123 Tarrytown, NY 10591 |
| Product Code | OMP |
| CFR Regulation Number | 878.4780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-02-23 |
| Decision Date | 2016-01-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 14260160094292 | K150459 | 000 |