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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Humidifier, Non-Direct Patient Interface (Home-Use)
510(k) Number K871189
Device Name SUNBEAM DURA-VAP WARM STEAM VAPORIZER MODEL 1380
Applicant
Sunbeam Appliance Service Co.
P.O. Box 1570
1333 Butterfield Rd.
Downers Grove,  IL  60515
Applicant Contact UHL
Correspondent
Sunbeam Appliance Service Co.
P.O. Box 1570
1333 Butterfield Rd.
Downers Grove,  IL  60515
Correspondent Contact UHL
Regulation Number868.5460
Classification Product Code
KFZ  
Date Received03/24/1987
Decision Date 05/08/1987
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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