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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
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