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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 K973829
Device Name IRRIGATION BOTTLE
Applicant
AUTOMATIC LIQUID PACKAGING, INC.
2200 W. LAKE SHORE DR.
WOODSTOCK,  IL  60098
Applicant Contact JOHN BRDA
Correspondent
AUTOMATIC LIQUID PACKAGING, INC.
2200 W. LAKE SHORE DR.
WOODSTOCK,  IL  60098
Correspondent Contact JOHN BRDA
Regulation Number868.5800
Classification Product Code
JOH  
Date Received10/07/1997
Decision Date 02/23/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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