The following data is part of a premarket notification filed by Vr Medical Technologies, Llc with the FDA for Vcare 1000-300s Pump, Vcare 1000-300s System, Perme-foam Dressing.
| Device ID | K162159 |
| 510k Number | K162159 |
| Device Name: | VCare 1000-300S Pump, VCare 1000-300S System, Perme-foam Dressing |
| Classification | Negative Pressure Wound Therapy Powered Suction Pump |
| Applicant | VR Medical Technologies, LLC 90 Gaoxin Rd. Kunshan, CN 215325 |
| Contact | Lee Pan |
| Correspondent | Lee Pan VR Medical Technologies, LLC 90 Gaoxin Rd. Kunshan, CN 215325 |
| Product Code | OMP |
| CFR Regulation Number | 878.4780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-08-02 |
| Decision Date | 2017-04-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50749756934799 | K162159 | 000 |
| 50749756934782 | K162159 | 000 |
| 00749756934015 | K162159 | 000 |
| 00749756950794 | K162159 | 000 |