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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 K854348
Device Name CHURCHILL 3-WAY STOPCOCK SET
Applicant
Churchill Corp.
One Summit Sq.
Rte. 413 & Doublewoods Rd.
Langhorne,  PA  19047
Applicant Contact DAVID W EVANS
Correspondent
Churchill Corp.
One Summit Sq.
Rte. 413 & Doublewoods Rd.
Langhorne,  PA  19047
Correspondent Contact DAVID W EVANS
Regulation Number880.5440
Classification Product Code
FMG  
Date Received10/29/1985
Decision Date 11/08/1985
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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