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.
Device ID | K121703 |
510k Number | K121703 |
Device Name: | LIPOKIT WITH DISPOSABLE 50CC AFT SYRINGE |
Classification | System, Suction, Lipoplasty |
Applicant | MEDI-KHAN USA, INC 399 MASSACHUSETTS AVE. #2 Boston, MA 02115 |
Contact | Kachi Enyinna |
Correspondent | Kachi Enyinna MEDI-KHAN USA, INC 399 MASSACHUSETTS AVE. #2 Boston, MA 02115 |
Product Code | MUU |
CFR Regulation Number | 878.5040 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2012-06-08 |
Decision Date | 2012-12-07 |
Summary: | summary |