Device Classification Name |
Holding Chambers, Direct Patient Interface
|
510(k) Number |
K140062 |
Device Name |
FSC ANTI-STATIC VALVED COLLAPSIBLE HOLDING CHAMBER |
Applicant |
FSC LABORATORIES, INC. |
6000 Fairview Rd. |
Suite 600 |
Charlotte,
NC
28210
|
|
Applicant Contact |
PAUL DRYDEN |
Correspondent |
FSC LABORATORIES, INC. |
6000 Fairview Rd. |
Suite 600 |
Charlotte,
NC
28210
|
|
Correspondent Contact |
PAUL DRYDEN |
Regulation Number | 868.5630
|
Classification Product Code |
|
Date Received | 01/10/2014 |
Decision Date | 10/03/2014 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|