The following data is part of a premarket notification filed by Nexa Medical Ltd. with the FDA for Nexa Negative Pressure Wound Therapy System.
| Device ID | K162610 |
| 510k Number | K162610 |
| Device Name: | NEXA Negative Pressure Wound Therapy System |
| Classification | Negative Pressure Wound Therapy Powered Suction Pump |
| Applicant | Nexa Medical Ltd. Suite 5-6, Willow View, Southfields, Church Lane Bournemouth, GB Bh22 8tr |
| Contact | Keith Heaton |
| Correspondent | Keith Heaton Nexa Medical Ltd. Suite 5-6, Willow View, Southfields, Church Lane Bournemouth, GB Bh22 8tr |
| Product Code | OMP |
| CFR Regulation Number | 878.4780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-09-19 |
| Decision Date | 2017-06-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15060826400035 | K162610 | 000 |
| 15060826400011 | K162610 | 000 |
| 15060826400066 | K162610 | 000 |
| 15060826400059 | K162610 | 000 |
| 15060826400004 | K162610 | 000 |