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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 and tube cuff
510(k) Number K921733
Device Name TRACHEOSTOMY CARE TRAY
Applicant
MEDIKMARK, INC.
333 WEST WACKER DR.
SUITE 2600
CHICAGO,  IL  60606
Applicant Contact RICHARD O WOOD
Correspondent
MEDIKMARK, INC.
333 WEST WACKER DR.
SUITE 2600
CHICAGO,  IL  60606
Correspondent Contact RICHARD O WOOD
Regulation Number868.5800
Classification Product Code
JOH  
Date Received04/10/1992
Decision Date 06/15/1994
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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