Device Classification Name |
filter, conduction, anesthetic
|
510(k) Number |
K083451 |
Device Name |
PORTEX EPIDURAL FILTER, MODEL 100/386/010, VARIOUS STANDARD AND CUSTOM TRAYS |
Applicant |
SMITHS MEDICAL ASD, INC. |
10 BOWMAN DR. |
KEENE,
NH
03431
|
|
Applicant Contact |
CYNTHIA ENGELHARDT |
Correspondent |
SMITHS MEDICAL ASD, INC. |
10 BOWMAN DR. |
KEENE,
NH
03431
|
|
Correspondent Contact |
CYNTHIA ENGELHARDT |
Regulation Number | 868.5130
|
Classification Product Code |
|
Date Received | 11/21/2008 |
Decision Date | 03/04/2009 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|