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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Reagent, Occult Blood
510(k) Number K002457
Device Name !NSURE FECAL OCCULT BLOOD TEST
Applicant
ENTERIX INC.
348 US ROUTE ONE
FALMOUTH,,  ME  04105
Applicant Contact ROBERT C BRUCE
Correspondent
ENTERIX INC.
348 US ROUTE ONE
FALMOUTH,,  ME  04105
Correspondent Contact ROBERT C BRUCE
Regulation Number864.6550
Classification Product Code
KHE  
Date Received08/10/2000
Decision Date 01/12/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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