Device Classification Name |
apparatus, gas-scavenging
|
510(k) Number |
K063519 |
Device Name |
DYNAMIC GAS SCAVENGING SYSTEM (DGSS) |
Applicant |
ANESTHETIC GAS RECLAMATION LLC |
3102 WEST END AVENUE |
700 TWO AMERICAN CENTER |
NASHVILLE,
TN
37203
|
|
Applicant Contact |
JAMES M BERRY |
Correspondent |
CITECH |
5200 BUTLER PIKE |
PLYMOUTH MEETING,
PA
19462 -1298
|
|
Correspondent Contact |
ROBERT MOSENKIS |
Regulation Number | 868.5430
|
Classification Product Code |
|
Date Received | 11/21/2006 |
Decision Date | 12/01/2006 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|