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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 K880317
Device Name PREFILLED SODIUM CHLORIDE SOLUTION FOR IRRIGA. USP
Applicant
Automatic Liquid Packaging, Inc.
2200 W. Lake Shore Dr.
Woodstock,  IL  60098
Applicant Contact FRANK LEO
Correspondent
Automatic Liquid Packaging, Inc.
2200 W. Lake Shore Dr.
Woodstock,  IL  60098
Correspondent Contact FRANK LEO
Regulation Number868.5800
Classification Product Code
BTO  
Date Received01/26/1988
Decision Date 02/29/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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