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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Hemodialyzer, Re-Use, Low Flux
510(k) Number K001685
Device Name PSN HEMODIALYZER, MODEL PSN 130, 150, 170, 210
Applicant
Baxter Healthcare Corp
1620 Waukegan Rd., Mpr-A2e
Mcgaw Park,  IL  60085
Applicant Contact ROBERT L WILKINSON
Correspondent
Baxter Healthcare Corp
1620 Waukegan Rd., Mpr-A2e
Mcgaw Park,  IL  60085
Correspondent Contact ROBERT L WILKINSON
Regulation Number876.5820
Classification Product Code
MSE  
Subsequent Product Code
MSF  
Date Received06/01/2000
Decision Date 11/15/2000
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
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