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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 K843730
Device Name SHILEY DISPOS. DECANNULATION PLUG W/SW/
Applicant
SHILEY, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
SHILEY, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number868.5800
Classification Product Code
BTO  
Date Received09/24/1984
Decision Date 10/19/1984
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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