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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tube, Tracheal (W/Wo Connector)
510(k) Number K881313
Device Name IQK-200
Applicant
Medical Repackers Co.
P.O. Box 1500
Fort Payne,  AL  35967
Applicant Contact BILLY A HODGES
Correspondent
Medical Repackers Co.
P.O. Box 1500
Fort Payne,  AL  35967
Correspondent Contact BILLY A HODGES
Regulation Number868.5730
Classification Product Code
BTR  
Date Received03/28/1988
Decision Date 05/19/1988
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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