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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 K862167
Device Name MINI-TRACH KIT
Applicant
PORTEX, INC.
42 INDUSTRIAL WAY
WILMINGTON,  MA  01887
Applicant Contact E. G GROVE
Correspondent
PORTEX, INC.
42 INDUSTRIAL WAY
WILMINGTON,  MA  01887
Correspondent Contact E. G GROVE
Regulation Number868.5800
Classification Product Code
BTO  
Date Received06/09/1986
Decision Date 08/06/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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