Device Classification Name |
Tube, Tracheal (W/Wo Connector)
|
510(k) Number |
K091591 |
Device Name |
FLEXICARE MEDICAL ENDOTRACHEAL TUBES |
Applicant |
FLEXICARE MEDICAL LTD. |
CYNON VALLEY BUSINESS PARK |
MOUTAIN ASH |
MID GLAMORGAN,
GB
CF45 4ER
|
|
Applicant Contact |
DAVID MOYNHAM |
Correspondent |
REGULATORY TECHNOLOGY SERVICES, LLC |
1000 Westgate Drive, |
Suite 510k |
Saint Paul,
MN
55114
|
|
Correspondent Contact |
MARK JOB |
Regulation Number | 868.5730
|
Classification Product Code |
|
Date Received | 06/02/2009 |
Decision Date | 06/17/2009 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|