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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 K874659
Device Name STERILIZATION OF DEVICES BY RADIATION
Applicant
Inhalation Plastics
7790 N. Merrimac
Chicago,  IL  60648
Applicant Contact JAMES LEKKAS
Correspondent
Inhalation Plastics
7790 N. Merrimac
Chicago,  IL  60648
Correspondent Contact JAMES LEKKAS
Regulation Number868.5450
Classification Product Code
BTT  
Date Received10/20/1987
Decision Date 02/02/1988
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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