The following data is part of a premarket notification filed by Medi-khan Usa, Inc with the FDA for Lipokit With Disposable 50cc Aft Syringe, Model Zlk-100.
| Device ID | K083455 |
| 510k Number | K083455 |
| Device Name: | LIPOKIT WITH DISPOSABLE 50CC AFT SYRINGE, MODEL ZLK-100 |
| Classification | System, Suction, Lipoplasty |
| Applicant | MEDI-KHAN USA, INC 1516 OAK STREET, SUITE 312 Alameda, CA 94501 |
| Contact | Julie Santiago |
| Correspondent | Julie Santiago MEDI-KHAN USA, INC 1516 OAK STREET, SUITE 312 Alameda, CA 94501 |
| Product Code | MUU |
| CFR Regulation Number | 878.5040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-11-21 |
| Decision Date | 2009-05-18 |
| Summary: | summary |