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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheters, suction, tracheobronchial
510(k) Number K843797
Device Name STERILE SALINE SOLUTION
Applicant
PACO PHARMACEUTICAL SERVICES, INC.
1200 PACO WAY
BUILDING 19
LAKEWOOD,  NJ  08701
Correspondent
PACO PHARMACEUTICAL SERVICES, INC.
1200 PACO WAY
BUILDING 19
LAKEWOOD,  NJ  08701
Regulation Number868.6810
Classification Product Code
BSY  
Date Received09/27/1984
Decision Date 01/18/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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