The following data is part of a premarket notification filed by Flexicare Medical Ltd. with the FDA for Flexicare Medical Endotracheal Tubes.
Device ID | K091591 |
510k Number | K091591 |
Device Name: | FLEXICARE MEDICAL ENDOTRACHEAL TUBES |
Classification | Tube, Tracheal (w/wo Connector) |
Applicant | FLEXICARE MEDICAL LTD. CYNON VALLEY BUSINESS PARK MOUTAIN ASH Mid Glamorgan, GB Cf45 4er |
Contact | David Moynham |
Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
Product Code | BTR |
CFR Regulation Number | 868.5730 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | Yes |
Combination Product | No |
Date Received | 2009-06-02 |
Decision Date | 2009-06-17 |
Summary: | summary |