Device Classification Name |
Vaporizer, Anesthesia, Non-Heated
|
510(k) Number |
K053564 |
Device Name |
KEYED FILLER BOTTLE ADAPTOR, MODELS 53450, 53452, 53453, 53454 |
Applicant |
PENLON LIMITED |
25 BARKER CLOSE |
FISHBOURNE, CHICHESTER |
WEST SUSSEX,
GB
PO18 8BJ
|
|
Applicant Contact |
BARRY PEARCE |
Correspondent |
PENLON LIMITED |
25 BARKER CLOSE |
FISHBOURNE, CHICHESTER |
WEST SUSSEX,
GB
PO18 8BJ
|
|
Correspondent Contact |
BARRY PEARCE |
Regulation Number | 868.5880
|
Classification Product Code |
|
Date Received | 12/22/2005 |
Decision Date | 03/03/2006 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|