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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 K871732
Device Name CHURCHILL-H VENTED IV SET W/METERING CHAMBERS
Applicant
Churchill Corp.
One Summit Square
Route 413 & Doublewoods Rd.
Langhorne,  PA  19047
Applicant Contact DAVID W EVANS
Correspondent
Churchill Corp.
One Summit Square
Route 413 & Doublewoods Rd.
Langhorne,  PA  19047
Correspondent Contact DAVID W EVANS
Regulation Number880.5440
Classification Product Code
FPA  
Date Received05/05/1987
Decision Date 06/15/1987
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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