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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Circuit, Breathing (W Connector, Adaptor, Y Piece)
510(k) Number K900428
Device Name ANESTHESIA BREATHING CIRCUITS
Applicant
Med-Tek Corp.
6685 N. Sidney Pl.
Glendale,  WI  53209
Applicant Contact ALAN E WHITMARSH
Correspondent
Med-Tek Corp.
6685 N. Sidney Pl.
Glendale,  WI  53209
Correspondent Contact ALAN E WHITMARSH
Regulation Number868.5240
Classification Product Code
CAI  
Date Received01/30/1990
Decision Date 08/17/1990
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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