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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Set, Administration, Intravascular
510(k) Number K854658
Device Name CHURCHILL - HBC VENTED BALL CHECK IV SET
Applicant
CHURCHILL CORP.
ONE SUMMIT SQUARE
ROUTE 413 & DOUBLEWOODS ROAD
LANGHORNE,  PA  19047
Applicant Contact DAVID EVANS
Correspondent
CHURCHILL CORP.
ONE SUMMIT SQUARE
ROUTE 413 & DOUBLEWOODS ROAD
LANGHORNE,  PA  19047
Correspondent Contact DAVID EVANS
Regulation Number880.5440
Classification Product Code
FPA  
Date Received11/20/1985
Decision Date 01/27/1986
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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