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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
Applicant Contact ANNE M PAHLMAN
Correspondent
Baxter Healthcare Corp
1620 Waulkegan Rd.
Mcgaw Park,  IL  60085
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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