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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheter, continuous flush
510(k) Number K792141
Device Name CONTINUOUS FLUSH DEVICE
Applicant
PHARMASEAL DIV., BAXTER HEALTHCARE CORP.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
PHARMASEAL DIV., BAXTER HEALTHCARE CORP.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number870.1210
Classification Product Code
KRA  
Date Received10/22/1979
Decision Date 12/05/1979
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
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