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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 K864113
Device Name CLYDE (TM) FILTRATION SYSTEM
Applicant
Arbor Technologies, Inc.
3728-1 Plz. Dr.
Ann Arbor,  MI  48104
Applicant Contact DAWN I MOORE
Correspondent
Arbor Technologies, Inc.
3728-1 Plz. Dr.
Ann Arbor,  MI  48104
Correspondent Contact DAWN I MOORE
Regulation Number880.5440
Classification Product Code
FPB  
Date Received10/21/1986
Decision Date 02/04/1987
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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