Device Classification Name |
Apparatus, Gas-Scavenging
|
510(k) Number |
K193646 |
Device Name |
Dynamic Gas Scavenging System 2 (DGSS - 2) |
Applicant |
Anesthetic Gas Reclamation, Inc. |
10606 Shady Trail #22 |
Dallas,
TX
75220
|
|
Applicant Contact |
James Berry |
Correspondent |
Ceutical Laboratories, Inc. |
2300 Valley View Lane Ste. 230 |
Farmers Branch,
TX
75234
|
|
Correspondent Contact |
Laurel Arrigona |
Regulation Number | 868.5430
|
Classification Product Code |
|
Date Received | 12/30/2019 |
Decision Date | 12/04/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|