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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 K880605
Device Name LABELING CHANGE FOR CUTTER PUREFLO PLUS IV FILTER
Applicant
Miles Laboratories, Inc.
4th & Parker St.
Post Office Box 1986
Berkeley,  CA  94701
Applicant Contact STERNBERG, PHD
Correspondent
Miles Laboratories, Inc.
4th & Parker St.
Post Office Box 1986
Berkeley,  CA  94701
Correspondent Contact STERNBERG, PHD
Regulation Number880.5440
Classification Product Code
FPB  
Date Received02/12/1988
Decision Date 05/26/1988
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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