The following data is part of a premarket notification filed by Anesthetic Gas Reclamation, Inc. with the FDA for Dynamic Gas Scavenging System 2 (dgss - 2).
| Device ID | K193646 |
| 510k Number | K193646 |
| Device Name: | Dynamic Gas Scavenging System 2 (DGSS - 2) |
| Classification | Apparatus, Gas-scavenging |
| Applicant | Anesthetic Gas Reclamation, Inc. 10606 Shady Trail #22 Dallas, TX 75220 |
| Contact | James Berry |
| Correspondent | Laurel Arrigona Ceutical Laboratories, Inc. 2300 Valley View Lane Ste. 230 Farmers Branch, TX 75234 |
| Product Code | CBN |
| CFR Regulation Number | 868.5430 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-12-30 |
| Decision Date | 2020-12-04 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00863573000408 | K193646 | 000 |