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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Syringe, Piston
510(k) Number K850958
Device Name BLOOD GAS SAMPLER KIT
Applicant
Churchill Corp.
P.O. Box 116
Pineville,  PA  18946
Applicant Contact DAVID W EVANS
Correspondent
Churchill Corp.
P.O. Box 116
Pineville,  PA  18946
Correspondent Contact DAVID W EVANS
Regulation Number880.5860
Classification Product Code
FMF  
Date Received03/08/1985
Decision Date 04/10/1985
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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