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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Container, I.V.
510(k) Number K041038
Device Name CHURCHILL MEDICAL DUAL CHAMBER EMPTY CONTAINER
Applicant
Churchill Medical Systems, Inc.
87 Venture Dr.
Enterprise Park
Dover,  NH  03820
Applicant Contact KEITH PALUCH
Correspondent
Churchill Medical Systems, Inc.
87 Venture Dr.
Enterprise Park
Dover,  NH  03820
Correspondent Contact KEITH PALUCH
Regulation Number880.5025
Classification Product Code
KPE  
Date Received04/22/2004
Decision Date 12/21/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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