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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Calibrator, Pressure, Gas
510(k) Number K923397
Device Name SINGLE DOSE GAS INJECTOR
Applicant
Escalon Medical Trek
820 Swan Dr.
Mukwonago,  WI  53149
Applicant Contact RONALD HUENEKE
Correspondent
Escalon Medical Trek
820 Swan Dr.
Mukwonago,  WI  53149
Correspondent Contact RONALD HUENEKE
Regulation Number868.2620
Classification Product Code
BXX  
Date Received07/10/1992
Decision Date 09/14/1992
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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