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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 K170548
Device Name InSure ONE
Applicant
Enterix, Inc.
236 Fernwood Ave.
Edison,  NJ  08837
Applicant Contact Michele Houldsworth
Correspondent
E Gold Solutions Consulting
19000 Saratoga Glen Place
Saratoga,  CA  95070
Correspondent Contact Ronald Schoengold
Regulation Number864.6550
Classification Product Code
KHE  
Date Received02/24/2017
Decision Date 10/05/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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