The following data is part of a premarket notification filed by Medigus Ltd. with the FDA for Muse System.
Device ID | K143634 |
510k Number | K143634 |
Device Name: | MUSE System |
Classification | Endoscopic Suture/plication System, Gastroesophageal Reflux Disease (gerd) |
Applicant | MEDIGUS LTD. BUILDING 7A, OMER IMDUSTRIAL PARK Omer, IL 84965 |
Contact | Sharon Kanety Deresh |
Correspondent | Sheila S Stevens MEDIGUS LTD. 2121 NORTH CALIFORNIA BLVD, SUITE 290 Walnut Creek, CA 94596 |
Product Code | ODE |
CFR Regulation Number | 876.1500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2014-12-22 |
Decision Date | 2015-01-20 |
Summary: | summary |