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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Gas-Machine, Anesthesia
510(k) Number K920944
Device Name FTS-200 GAS SYSTEM
Applicant
Trek Medical Products, Inc.
820 Swan Dr.
P.O. Box B
Muckwonago,  WI  53149
Applicant Contact RONALD HUENEKE
Correspondent
Trek Medical Products, Inc.
820 Swan Dr.
P.O. Box B
Muckwonago,  WI  53149
Correspondent Contact RONALD HUENEKE
Regulation Number868.5160
Classification Product Code
BSZ  
Date Received03/02/1992
Decision Date 05/29/1992
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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