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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tube, Laryngectomy
510(k) Number K873992
Device Name LARYNGECTOMY TUBE
Applicant
Portex, Inc.
42 Industrial Way
Wilmington,  MA  01887
Applicant Contact EDWIN G GROVE
Correspondent
Portex, Inc.
42 Industrial Way
Wilmington,  MA  01887
Correspondent Contact EDWIN G GROVE
Regulation Number874.4420
Classification Product Code
KAC  
Date Received10/01/1987
Decision Date 03/24/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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