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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Calculator, Drug Dose
510(k) Number K181916
Device Name d-Nav System
Applicant
Hygieia, Inc.
28803 8 Mile Rd., Suite 101
Livonia,  MI  48152
Applicant Contact Kimberly Chaperon
Correspondent
Hygieia, Inc.
28803 8 Mile Rd., Suite 101
Livonia,  MI  48152
Correspondent Contact Kimberly Chaperon
Regulation Number868.1890
Classification Product Code
NDC  
Date Received07/17/2018
Decision Date 02/04/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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