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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, dialysate delivery, single patient
510(k) Number K922757
Device Name SPS 1550 SINGLE NEEDLE PATIENT SYSTEM
Applicant
BAXTER HEALTHCARE CORP.
1620 WAULKEGAN RD.
MCGAW PARK,  IL  60085 -6730
Applicant Contact ANNE M PAHLMAN
Correspondent
BAXTER HEALTHCARE CORP.
1620 WAULKEGAN RD.
MCGAW PARK,  IL  60085 -6730
Correspondent Contact ANNE M PAHLMAN
Regulation Number876.5820
Classification Product Code
FKP  
Date Received06/09/1992
Decision Date 02/13/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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