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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Tent, Oxygen, Electrically Powered
510(k) Number K813235
Device Name DISS FEMALE AIR ADAPTOR
Applicant
Timeter Instrument Corp.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Timeter Instrument Corp.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number868.5710
Classification Product Code
BYK  
Date Received11/17/1981
Decision Date 12/08/1981
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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