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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mixer, Breathing Gases, Anesthesia Inhalation
510(k) Number K800866
Device Name ROYAL
Applicant
Trident Dental, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Trident Dental, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number868.5330
Classification Product Code
BZR  
Date Received04/16/1980
Decision Date 05/28/1980
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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