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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
510(k) Number K872585
Device Name CHURCHILL-CATH
Applicant
CHURCHILL CORP.
ONE SUMMIT SQUARE
ROUTE 413 & DOUBLEWOODS ROAD
LANGHORNE,  PA  19047
Applicant Contact DAVID W EVANS
Correspondent
CHURCHILL CORP.
ONE SUMMIT SQUARE
ROUTE 413 & DOUBLEWOODS ROAD
LANGHORNE,  PA  19047
Correspondent Contact DAVID W EVANS
Regulation Number880.5200
Classification Product Code
FOZ  
Date Received07/01/1987
Decision Date 10/15/1987
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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