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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 K000964
Device Name STERILE WATER OR O.9% SODIUM CHLORIDE, MODEL AL4100 & AL4109
Applicant
AUTOMATIC LIQUID PACKAGING, INC.
2200 LAKE SHORE DR.
WOODSTOCK,  IL  60098
Applicant Contact JOHN BRDA
Correspondent
AUTOMATIC LIQUID PACKAGING, INC.
2200 LAKE SHORE DR.
WOODSTOCK,  IL  60098
Correspondent Contact JOHN BRDA
Regulation Number868.5800
Classification Product Code
JOH  
Subsequent Product Code
BTR  
Date Received03/27/2000
Decision Date 04/25/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Special
Reviewed by Third Party No
Combination Product No
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