The following data is part of a premarket notification filed by Carilex Medical, Inc. with the FDA for Vt Dressing Kits.
| Device ID | K172725 |
| 510k Number | K172725 |
| Device Name: | VT Dressing Kits |
| Classification | Negative Pressure Wound Therapy Powered Suction Pump |
| Applicant | Carilex Medical, Inc. No. 77 Keji 1st Rd., Guishan Dist. Taoyuan City, TW 333 |
| Contact | Henry Kao |
| Correspondent | Maria Griffin mdi Consultants, Inc. 55 Northern Blvd. Great Neck, NY 11021 |
| Product Code | OMP |
| CFR Regulation Number | 878.4780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-09-11 |
| Decision Date | 2018-06-08 |
| Summary: | summary |