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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 K850456
Device Name TRACHEOSTOMY CARE KIT
Applicant
EXCEL HEALTH CARE PRODUCTS
5001 HADLEY RD.
SOUTH PLAINFIELD,  NJ  07080
Applicant Contact DAVID CATLIN
Correspondent
EXCEL HEALTH CARE PRODUCTS
5001 HADLEY RD.
SOUTH PLAINFIELD,  NJ  07080
Correspondent Contact DAVID CATLIN
Regulation Number868.5800
Classification Product Code
BTO  
Date Received02/06/1985
Decision Date 03/11/1985
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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