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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Condenser, Heat And Moisture (Artificial Nose)
510(k) Number K953540
Device Name EEE
Applicant
Edentec Corp.
10252 Valley View Rd.
Eden Prairie,  MN  55344
Applicant Contact CHRIS HADLAND
Correspondent
Edentec Corp.
10252 Valley View Rd.
Eden Prairie,  MN  55344
Correspondent Contact CHRIS HADLAND
Regulation Number868.5375
Classification Product Code
BYD  
Date Received07/28/1995
Decision Date 08/25/1995
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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