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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tube, Tracheostomy (W/Wo Connector)
510(k) Number K810321
Device Name REINFORCED TRACHEOSTOMY TUBE SET(TENTAT)
Applicant
National Catheter Co. Div. Mallinckrodt
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
National Catheter Co. Div. Mallinckrodt
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number868.5800
Classification Product Code
BTO  
Date Received02/06/1981
Decision Date 03/04/1981
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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