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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 K894954
Device Name .22 & 1.2 MICRON IV FILTERS
Applicant
Churchill Medical Systems, Inc.
905 Sheehy Dr.
Horsham,  PA  19044
Applicant Contact JOEL A MARCUS
Correspondent
Churchill Medical Systems, Inc.
905 Sheehy Dr.
Horsham,  PA  19044
Correspondent Contact JOEL A MARCUS
Regulation Number880.5440
Classification Product Code
FPB  
Date Received08/04/1989
Decision Date 11/13/1989
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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