Device Classification Name |
apparatus, gas-scavenging
|
510(k) Number |
K080039 |
Device Name |
PASSIVE WASTE GAS SCAVENGER, MODEL 14600 |
Applicant |
G. DUNDAS CO.,INC. |
24301 ROBERTS DR. |
BLACK DIAMOND,
WA
98010
|
|
Applicant Contact |
MARIO SORCI |
Correspondent |
G. DUNDAS CO.,INC. |
24301 ROBERTS DR. |
BLACK DIAMOND,
WA
98010
|
|
Correspondent Contact |
MARIO SORCI |
Regulation Number | 868.5430
|
Classification Product Code |
|
Date Received | 01/07/2008 |
Decision Date | 04/14/2008 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|