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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Filter, Infusion Line
510(k) Number K851817
Device Name SARTORIUS MINI-SART FH 16555
Applicant
Sartorius Filters, Inc.
30940 San Clemente St.
Hayward,  CA  94544
Applicant Contact STEVEN CATES
Correspondent
Sartorius Filters, Inc.
30940 San Clemente St.
Hayward,  CA  94544
Correspondent Contact STEVEN CATES
Regulation Number880.5440
Classification Product Code
FPB  
Date Received04/26/1985
Decision Date 08/19/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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