Device Classification Name |
filter, bacterial, breathing-circuit
|
510(k) Number |
K002506 |
Device Name |
BREATHING FILTER FOR DISPOSABLE ANESTHESIA BREATHING CIRCUIT |
Applicant |
SIMS PORTEX, INC. |
10 BOWMAN DR. |
KEENE,
NH
03431
|
|
Applicant Contact |
TIMOTHY J TALCOTT |
Correspondent |
SIMS PORTEX, INC. |
10 BOWMAN DR. |
KEENE,
NH
03431
|
|
Correspondent Contact |
TIMOTHY J TALCOTT |
Regulation Number | 868.5260
|
Classification Product Code |
|
Date Received | 08/15/2000 |
Decision Date | 12/14/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
General Hospital
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|