The following data is part of a premarket notification filed by Arco Medic Ltd. with the FDA for Flexiblade.
Device ID | K984101 |
510k Number | K984101 |
Device Name: | FLEXIBLADE |
Classification | Laryngoscope, Rigid |
Applicant | ARCO MEDIC LTD. 117 AHUZAH ST. Ra'ananna, IL 43373 |
Contact | Shoshana Friedman |
Correspondent | Shoshana Friedman ARCO MEDIC LTD. 117 AHUZAH ST. Ra'ananna, IL 43373 |
Product Code | CCW |
CFR Regulation Number | 868.5540 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1998-11-17 |
Decision Date | 1999-09-03 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
FLEXIBLADE 77627129 3832611 Dead/Cancelled |
MIW Associates LLC 2008-12-05 |
FLEXIBLADE 76564300 not registered Dead/Abandoned |
Innovation Factory, Inc. 2003-11-28 |
FLEXIBLADE 76363259 2807825 Live/Registered |
SPEED FRANCE S.A.S. 2002-01-26 |