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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 K920281
Device Name TRACHEOSTOMY CARE KIT, STERILE, DISPOSABLE
Applicant
TRINITY LABORATORIES, INC.
P.O. BOX 4458
201 KILEY DRIVE
SALISBURY,  MD  21803
Applicant Contact PARTHA BASUMALLIK
Correspondent
TRINITY LABORATORIES, INC.
P.O. BOX 4458
201 KILEY DRIVE
SALISBURY,  MD  21803
Correspondent Contact PARTHA BASUMALLIK
Regulation Number868.5800
Classification Product Code
BTO  
Date Received01/22/1992
Decision Date 08/27/1992
Decision Substantially Equivalent - Kit (SESK)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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