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 |