The following data is part of a premarket notification filed by Kms Medical Llc with the FDA for Endoguide.
Device ID | K063654 |
510k Number | K063654 |
Device Name: | ENDOGUIDE |
Classification | Colonoscope And Accessories, Flexible/rigid |
Applicant | KMS MEDICAL LLC 7290 SW 42ND STREET Miami, FL 33155 |
Contact | Mario Arbesu |
Correspondent | Mario Arbesu KMS MEDICAL LLC 7290 SW 42ND STREET Miami, FL 33155 |
Product Code | FDF |
CFR Regulation Number | 876.1500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2006-12-08 |
Decision Date | 2007-01-31 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
ENDOGUIDE 85106228 3976015 Live/Registered |
S.S. White Burs, Inc. 2010-08-12 |
ENDOGUIDE 77029080 not registered Dead/Abandoned |
SYNTHEON, LLC 2006-10-25 |
ENDOGUIDE 73797906 1577505 Dead/Cancelled |
LUXAR CORPORATION 1989-05-05 |