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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 K930114
Device Name TRACHEOSTOMY T-TUBE
Applicant
Invotec International, Inc.
11221- 5 St. Johns Industrial
Pkwy.
Jacksonville,  FL  32216
Applicant Contact JEFFREY L HULL
Correspondent
Invotec International, Inc.
11221- 5 St. Johns Industrial
Pkwy.
Jacksonville,  FL  32216
Correspondent Contact JEFFREY L HULL
Regulation Number868.5730
Classification Product Code
BTR  
Date Received01/11/1993
Decision Date 03/19/1993
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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