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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
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