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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stopcock, I.V. Set
510(k) Number K012157
Device Name CHURCHILL MEDICAL SYSTEMS STOPCOCK
Applicant
Churchill Medical Systems, Inc.
87 Venture Dr.
Dover,  NH  03820
Applicant Contact KEITH PALUCH
Correspondent
Churchill Medical Systems, Inc.
87 Venture Dr.
Dover,  NH  03820
Correspondent Contact KEITH PALUCH
Regulation Number880.5440
Classification Product Code
FMG  
Date Received07/11/2001
Decision Date 09/11/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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