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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name single use only blood lancet with an integral sharps injury prevention feature
510(k) Number K854760
Device Name CHURCHHILL LANCET
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 Number878.4850
Classification Product Code
FMK  
Date Received11/27/1985
Decision Date 01/03/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
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