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U.S. Department of Health and Human Services

510(k) Premarket Notification
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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 Trl. #22
Dallas,  TX  75220
Applicant Contact James Berry
Correspondent
Ceutical Laboratories, Inc.
2300 Valley View Ln. Suite 230
Farmers Branch,  TX  75234
Correspondent Contact Laurel Arrigona
Regulation Number868.5430
Classification Product Code
CBN  
Date Received12/30/2019
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
Predetermined Change
Control Plan Authorized		 No
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