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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 K872634
Device Name CUTTER PUREFLO PLUS IV FILTER
Applicant
Miles Laboratories, Inc.
4th & Parker St.
Post Office Box 1986
Berkeley,  CA  94701
Applicant Contact M STERNBERG
Correspondent
Miles Laboratories, Inc.
4th & Parker St.
Post Office Box 1986
Berkeley,  CA  94701
Correspondent Contact M STERNBERG
Regulation Number880.5440
Classification Product Code
FPB  
Date Received07/06/1987
Decision Date 08/04/1987
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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