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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name set, i.v. fluid transfer
510(k) Number K852467
Device Name VIAL VENT FILTER
Applicant
BAXTER HEALTHCARE CORP.
londonderry turnpike
hooksett,  NH  03104
Applicant Contact roger a leroux
Correspondent
BAXTER HEALTHCARE CORP.
londonderry turnpike
hooksett,  NH  03104
Correspodent Contact roger a leroux
Regulation Number880.5440
Classification Product Code
LHI  
Date Received06/10/1985
Decision Date 10/17/1985
Decision substantially equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
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