The following data is part of a premarket notification filed by Anesthetic Gas Reclamation Llc with the FDA for Dynamic Gas Scavenging System (dgss).
Device ID | K063519 |
510k Number | K063519 |
Device Name: | DYNAMIC GAS SCAVENGING SYSTEM (DGSS) |
Classification | Apparatus, Gas-scavenging |
Applicant | ANESTHETIC GAS RECLAMATION LLC 3102 WEST END AVENUE 700 TWO AMERICAN CENTER Nashville, TN 37203 |
Contact | James M Berry |
Correspondent | Robert Mosenkis CITECH 5200 BUTLER PIKE Plymouth Meeting, PA 19462 -1298 |
Product Code | CBN |
CFR Regulation Number | 868.5430 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | Yes |
Combination Product | No |
Date Received | 2006-11-21 |
Decision Date | 2006-12-01 |
Summary: | summary |