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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pump, Infusion
510(k) Number K871084
Device Name NITROGLYCERINE PUMP 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 Number880.5725
Classification Product Code
FRN  
Date Received03/18/1987
Decision Date 07/16/1987
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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