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 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 14719873695987 | K172725 | 000 |
| 04713616094603 | K172725 | 000 |
| 04713616091503 | K172725 | 000 |
| 04713616091480 | K172725 | 000 |
| 04713616092890 | K172725 | 000 |
| 04719873693658 | K172725 | 000 |
| 04719873693641 | K172725 | 000 |
| 04719873693634 | K172725 | 000 |
| 04713616091343 | K172725 | 000 |
| 04719873693597 | K172725 | 000 |
| 04719873693580 | K172725 | 000 |
| 04713616094634 | K172725 | 000 |
| 04719873691234 | K172725 | 000 |
| 14719873695741 | K172725 | 000 |
| 04719873695607 | K172725 | 000 |
| 04719873695218 | K172725 | 000 |
| 04719873695188 | K172725 | 000 |
| 04719873695157 | K172725 | 000 |
| 04719873695065 | K172725 | 000 |
| 04719873695034 | K172725 | 000 |
| 04719873695003 | K172725 | 000 |
| 04719873694976 | K172725 | 000 |
| 04719873694945 | K172725 | 000 |
| 04713616090223 | K172725 | 000 |