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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 K013321
Device Name SILICONE TRACHEAL T-TUBES
Applicant
Technical Products, Inc.
2416 Park Central Blvd.
Decatur,  GA  30035
Applicant Contact NORBERT D THOMPSON
Correspondent
Technical Products, Inc.
2416 Park Central Blvd.
Decatur,  GA  30035
Correspondent Contact NORBERT D THOMPSON
Regulation Number868.5730
Classification Product Code
BTR  
Date Received10/05/2001
Decision Date 06/04/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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