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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Humidifier, Respiratory Gas, (Direct Patient Interface)
510(k) Number K983783
Device Name HEATED HUMIDIFIER
Applicant
Pegasus Research Corp.
1714 S. Lyon St.
Santa Ana,  CA  92705
Applicant Contact E J SMITH
Correspondent
Pegasus Research Corp.
1714 S. Lyon St.
Santa Ana,  CA  92705
Correspondent Contact E J SMITH
Regulation Number868.5450
Classification Product Code
BTT  
Date Received10/27/1998
Decision Date 10/24/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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